U.S. patent number 7,147,633 [Application Number 10/099,528] was granted by the patent office on 2006-12-12 for method and apparatus for treatment of atrial fibrillation.
This patent grant is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to U. Hiram Chee, James R. Kermode, Richard L. Mueller, Douglas Murphy-Chutorian, Curtis P. Tom.
United States Patent |
7,147,633 |
Chee , et al. |
December 12, 2006 |
Method and apparatus for treatment of atrial fibrillation
Abstract
Methods and apparatus of embodiments of the invention are
adapted to treat tissue inside a patient's body. Aspects of the
invention can be used in a wide variety of applications, but
certain embodiments provide minimally invasive alternatives for
treating atrial fibrillation by delivering a tissue-damaging agent
to selected areas of the heart. One exemplary embodiment of the
invention provides a method of treating cardiac arrhythmia. This
method includes positioning a distal tissue-contacting portion of a
body in surface contact with a tissue surface of cardiac tissue;
detecting the surface contact between the tissue-contacting portion
and the tissue surface; and thereafter, injecting a tissue-ablating
agent into the cardiac tissue through the tissue-contacting portion
of the body.
Inventors: |
Chee; U. Hiram (Santa Cruz,
CA), Mueller; Richard L. (Byron, CA), Kermode; James
R. (Los Altos, CA), Tom; Curtis P. (San Mateo, CA),
Murphy-Chutorian; Douglas (Palo Alto, CA) |
Assignee: |
Boston Scientific Scimed, Inc.
(Maple Grove, MN)
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Family
ID: |
27536940 |
Appl.
No.: |
10/099,528 |
Filed: |
March 14, 2002 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20020183738 A1 |
Dec 5, 2002 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60340980 |
Dec 7, 2001 |
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60327053 |
Oct 3, 2001 |
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60275923 |
Mar 14, 2001 |
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60137265 |
Jun 2, 1999 |
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Current U.S.
Class: |
606/41; 606/51;
607/104; 607/101; 606/52; 606/49; 606/48 |
Current CPC
Class: |
A61B
17/282 (20130101); A61B 17/32037 (20130101); A61B
17/3207 (20130101); A61B 2017/00243 (20130101); A61B
2017/00247 (20130101); A61B 2017/22077 (20130101); A61B
2018/00392 (20130101); A61B 2018/00839 (20130101); A61B
2018/00875 (20130101); A61B 2018/1425 (20130101); A61B
2218/002 (20130101); A61M 5/30 (20130101); A61M
37/0092 (20130101); A61M 2025/0089 (20130101); A61B
2090/064 (20160201); A61B 2090/067 (20160201); A61B
34/20 (20160201) |
Current International
Class: |
A61B
18/18 (20060101) |
Field of
Search: |
;606/41,54-47,45-52
;607/115,116,122,101,104,105,113,119 |
References Cited
[Referenced By]
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WO 00/72908 |
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WO 01 05306 |
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WO |
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Primary Examiner: Rollins; Rosiland
Attorney, Agent or Firm: Jones Day
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION(S)
This application claims priority from the following U.S. patent
applications, each of which is incorporated herein by reference in
its entirety: U.S. Provisional Patent Application 60/137,265, filed
Jun. 2, 1999; U.S. patent application Ser. No. 09/585,983, titled
"Devices and Methods for Delivering a Drug" filed Jun. 2, 2000;
International Application No. PCT/US00/15386, titled "Devices and
Methods for Delivering a Drug" filed Jun. 2, 2000 (which was
published in English 7 Dec. 2000 as International Publication No.
WO 00/72908); U.S. Provisional Patent Application No. 60/275,923,
titled "Sensor Device and Apparatus for Affecting a Body Tissue at
an Internal Target Region" filed Mar. 14, 2001; U.S. Provisional
Patent Application No. 60/327,053, titled "Method and Apparatus for
Guided Interventional Procedures" filed Oct. 3, 2001; and U.S.
Provisional Patent Application No. 60/340,980, titled "Method and
Apparatus for Treatment of Atrial Fibrillation" filed Dec. 7, 2001.
Claims
What is claimed is:
1. A medical device for treating tissue comprising: a fluid
reservoir; a first tissue contacting member adapted to be
manipulated into contact with a surface of a target tissue, the
first tissue contacting member having a body, first and second
tissue-contacting surfaces spaced apart from one another to define
a gap therebetween, and a recess proximate to the gap; and a first
fluid delivery conduit in fluid communication with the reservoir
and having a plurality of outlet ports, the first fluid delivery
conduit having a length received in the recess, wherein the outlet
ports are oriented toward the gap and the first fluid delivery
conduit is spaced apart from the plane extending across the gap
such that the first fluid delivery conduit does not contact the
tissue.
2. The medical device of claim 1 further comprising a second tissue
contacting member having a body and a tissue-contacting surface,
the second tissue contacting member being operatively associated
with the first tissue contacting member to permit movement between
an open configuration and a closed configuration, the
tissue-contacting surfaces of the first tissue contacting members
being oriented generally toward the second tissue contacting member
in the closed configuration.
3. The medical device of claim 1 further comprising: a second
tissue contacting member having a body, first and second
tissue-contacting surfaces spaced from one another to define a
second gap therebetween, and a second recess proximate to the gap,
the second tissue contacting member being operatively associated
with the first tissue contacting member to permit movement between
an open configuration and a closed configuration, the
tissue-contacting surfaces of the first and second tissue
contacting members being oriented generally toward one another in
the closed configuration; and a second fluid delivery conduit in
fluid communication with the reservoir and having a plurality of
outlet ports, the second fluid delivery conduit having a length
received in the second recess with the outlet ports oriented
toward, but spaced from, the second gap.
4. The medical device of claim 3 further comprising an elongate
body sized to be introduced into a thoracic cavity through an
intercostal incision, the first tissue contacting member and the
second tissue contacting member being disposed adjacent a distal
end of the body, and a manually operable actuator spaced proximally
from the distal end of the body and adapted to move the first and
second tissue contacting members between the open and closed
configurations.
5. The medical device of claim 1 wherein the first tissue
contacting member carries a tissue contacting sensor.
6. The medical device of claim 5 wherein the contact sensor
comprises a pair of electrodes, one electrode of the pair being
carried on the first tissue-contacting surface and the other
electrode of the pair being carried on the second tissue-contacting
surface.
7. The medical device of claim 1 wherein the ports of the conduit
are spaced a distance from a plane extending between the first and
second tissue-contacting surfaces.
8. The medical device of claim 1 further comprising a pressure
control in fluid communication with the reservoir, the pressure
control being operable to establish an elevated pressure within the
fluid delivery conduit sufficient to propel a fluid in the fluid
reservoir through the outlet ports to define a plurality of
spaced-apart fluid jets capable of penetrating a target tissue to a
gap of at least about 2 mm.
9. The medical device of claim 8 wherein the pressure control is
operable to establish an elevated delivery pressure of about 600
2000 psi.
10. The medical device of claim 8 wherein the pressure control is
operable to define the fluid jets capable of penetrating an entire
thickness of a patient's myocardium.
11. The medical device of claim 1 further comprising a
tissue-ablating agent in the reservoir, the tissue-ablating agent
comprising a fluid selected from the group consisting of alcohols,
hypertonic saline, hot saline, hot glycerine, hot ethylene glycol,
cold saline, cold glycerine, cold ethylene glycol, sodium
tetradecyl sulfate, and polyethyleneglycolmonododecylether.
12. A medical device for treating tissue comprising: a fluid
reservoir; a tissue grasping member comprising a first tissue
contacting member and an opposed second tissue contacting member,
the first and second tissue contacting members being operatively
associated with one another and movable between a first
configuration wherein they have a first relative orientation
adapted to receive the tissue therebetween and a second
configuration wherein they have a second relative orientation
adapted to grasp the tissue therebetween; wherein the first and
second tissue contacting members each have first and second tissue
contacting surfaces spaced apart from one another to define a gap
therebetween, and first and second fluid delivery conduits in fluid
communication with the reservoir, the first fluid delivery conduit
having a distal length carried by the first tissue contacting
member and a plurality of outlet ports spaced along that distal
length, and the second fluid delivery conduit having a distal
length carried by the second tissue contacting member and a
plurality of outlet ports spaced along that distal length, the
outlet ports of the first and second fluid delivery conduits being
oriented generally inwardly toward one another when the tissue
grasping member is in the second configuration, wherein the first
and second delivery conduits are spaced apart from the planes
extending across the gaps such that the first and second delivery
conduits do not contact the tissue.
13. The medical device of claim 12 wherein the tissue grasping
member carries a tissue contact sensor.
14. The medical device of claim 13 wherein the tissue contact
sensor comprises a pair of electrodes.
15. The medical device of claim 12 wherein the first tissue
contacting member includes an elongate first recess within which
the distal length of the first fluid delivery conduit is received
and the second tissue contacting member includes an elongate second
recess within which the distal length of the second fluid delivery
conduit is received.
16. The medical device of claim 15 wherein the first tissue
contacting member has a first tissue-contacting face having a first
gap therein, the outlet ports of the first fluid delivery conduit
being oriented toward, but spaced from, the first gap, and the
second tissue contacting member has a second tissue contacting face
having a second gap therein, the outlet ports of the second fluid
delivery conduit being oriented toward, but spaced from, the second
gap.
17. A medical device for treating cardiac arrhythmia, comprising: a
fluid reservoir for receiving an injectable tissue-ablating agent;
an elongate body adapted for introduction into a thoracic cavity,
the body having a distal tissue-contacting member having first and
second tissue contacting surfaces spaced apart from one another to
define a gap therebetween, a first fluid delivery conduit in
communication with the fluid reservoir having a plurality of outlet
ports, wherein the first fluid delivery conduit is spaced apart
from the plane extending across the gap such that the first fluid
delivery conduit does not contact a desired tissue; a lumen in the
body communicating the reservoir with the outlet ports; a pressure
control in fluid communication with the reservoir, the pressure
control being operable to establish an elevated pressure within the
lumen sufficient to propel the tissue-ablating agent from the fluid
supply through the outlet ports to define a plurality of
spaced-apart fluid jets capable of penetrating the target tissue to
a depth of at least about 2 mm.
18. The medical device of claim 17 wherein the pressure control is
operable to establish an elevated delivery pressure of at least
about 400 psi.
19. The medical device of claim 17 wherein the pressure control is
operable to establish an elevated delivery pressure of about 600
2000 psi.
20. The medical device of claim 17 wherein the pressure control is
operable to define the fluid jets capable of penetrating an entire
thickness of a patient's myocardium.
21. The medical device of claim 17 wherein the tissue-contacting
member includes a tissue contact sensor.
22. The medical device of claim 21 wherein the tissue contact
sensor is operatively coupled to an EKG display.
23. The medical device of claim 21 wherein the tissue contact
sensor comprises at least two electrodes spaced from one another
along a tissue-contacting surface of the tissue-contacting member
of the body.
24. The medical device of claim 23 wherein the electrodes are
operatively coupled to an EKG display.
25. The medical device of claim 17 wherein the tissue-contacting
member is flexible and adapted to conform to a surface of a target
tissue.
26. The medical device of claim 25 wherein the tissue-contacting
member has a predetermined curvature in a natural, relaxed state
and tends to resiliently return toward the relaxed state when
conforming to the surface of the target tissue.
27. The medical device of claim 25 wherein a proximal length of the
body is flexible.
28. The medical device of claim 17 wherein the plurality of ports
comprises a series of ports aligned along a tissue-contacting
surface of the tissue-contacting member of the body.
29. The medical device of claim 17 further comprising a
tissue-ablating agent in the reservoir, the tissue-ablating agent
comprising a fluid selected from the group consisting of alcohols,
hypertonic saline, hot saline, hot glycerine, hot ethylene glycol,
cold saline, cold glycerine, cold ethylene glycol, sodium
tetradecyl sulfate, and polyethyleneglycolmonododecylether.
30. The medical device of claim 17 further comprising a
tissue-ablating agent in the reservoir, the tissue-ablating agent
comprising a fluid selected from the group consisting of ethanol,
hypertonic saline, hot saline, hot glycerine, hot ethylene glycol,
cold saline, cold glycerine, and cold ethylene glycol.
31. The medical device of claim 17 further comprising a
tissue-ablating agent in the reservoir, the tissue-ablating agent
being selected to damage tissue into which it is injected, yet
permit introduction of excess tissue-ablating agent into the
patient's bloodstream.
32. The medical device of claim 31 wherein the tissue-ablating
agent comprises a fluid selected from the group consisting of
ethanol, hypertonic saline, hot saline, hot glycerine, hot ethylene
glycol, cold saline, cold glycerine, and cold ethylene glycol.
Description
TECHNICAL FIELD
Embodiments of the invention relate generally to medical procedures
and interventional medical devices that can be used to treat
cardiac arrhythmias and other conditions. Many of these embodiments
have particular utility in treating atrial fibrillation.
BACKGROUND
A wide variety of diseases and maladies can be treated by surgical
intervention. Increasingly, however, less invasive procedures are
sought to achieve similar objectives while reducing risks and
recovery time associated with more traditional surgical approaches.
For example, a variety of thoracic surgical procedures, such as
treatment of aortic aneurysms and arterial stenosis, were
traditionally performed via a gross thoracotomy. Less invasive
procedures, such as balloon-expanded stents and PTCA, have been
developed which avoid the need for a gross thoracotomy, requiring
instead only a small incision to gain access to the thoracic cavity
intravascularly or through an intercostal opening.
Cardiac arrhythmias present a significant health problem. Cardiac
arrhythmias include ventricular tachycardias, supra ventricular
tachycardias, and atrial fibrillation. Of these, atrial
fibrillation is the most common cardiac arrhythmia. It has been
estimated that over one million people in the United States alone
suffer from atrial fibrillation. Incidence of atrial fibrillation
is expected to increase over the next several decades as
populations in the United States and Europe trend older because
atrial fibrillation tends to become more common with increasing
age.
Atrial fibrillation may be treated with medication intended to
maintain normal sinus rhythm and/or decrease ventricular response
rates. Not all atrial fibrillation may be successfully managed with
medication, though. A surgical approach was developed to create an
electrical maze in the atrium with the intention of preventing the
atria from fibrillating. Known, appropriately, as the "maze"
procedure, this technique involves making atrial incisions which
interrupt pathways for reentry circuits which can cause atrial
fibrillation and instead direct the cardiac electrical impulse
through both atria before allowing the signal to activate the
ventricles. As a result, virtually the entire atrial myocardium,
with the exception of the atrial appendages and the pulmonary
veins, can be electrically activated. The maze procedure is very
effective in reducing or eliminating atrial fibrillation.
Unfortunately, the procedure is difficult to perform and has
traditionally required a gross thoracotomy and cardiopulmonary
bypass to permit the surgeon appropriate access to the patient's
heart.
Several less invasive techniques have been proposed for achieving a
similar maze-like effect in the atrial myocardium without requiring
direct surgical intervention. For example, U.S. Pat. No. 6,267,760
(Swanson) and U.S. Pat. No. 6,237,605 (Vaska et al.), both of which
are incorporated entirely herein by reference, suggest RF ablation
devices intended to ablate cardiac tissue and create atrial
myocardial lesions to achieve much the same purpose as the surgical
incisions of the standard maze procedure. U.S. Pat. No. 6,161,543
(Cox et al.), which is also incorporated entirely herein by
reference, suggests that a cryogenic probe be employed to freeze
tissue instead of using the RF ablation devices to heat tissue.
Each of these approaches leaves something to be desired,
however.
SUMMARY
Embodiments of the present invention provide methods and apparatus
adapted to treat tissue inside a patient's body. Some of the
embodiments of the invention can be used in a wide variety of
applications to treat a number of diseases or conditions. For
example, embodiments of the invention can be used to accurately
deliver a therapeutic agent (e.g., DNA for gene therapy) to a
diseased tissue or deliver an angiogenic substance to induce
angiogenesis in hypoxic tissue.
One embodiment of the invention provides a medical device adapted
to treat patient tissue which includes a fluid reservoir, a tissue
contacting member, and a fluid delivery conduit. The tissue
contacting member is adapted to be manipulated into contact with a
surface of a target tissue. It also includes a body, first and
second tissue-contacting surfaces spaced from one another to define
a gap therebetween, and a recess proximate to the gap. The fluid
delivery conduit is in fluid communication with the reservoir and
has a plurality of outlet ports. A length of the fluid delivery
conduit is received in the recess with the outlet ports oriented
toward, but spaced from, the gap.
Another embodiment of the invention provides an alternative medical
device which includes a fluid reservoir, a tissue grasping member,
and first and second fluid delivery conduits in fluid communication
with the reservoir. The tissue grasping member has a first tissue
contacting member and an opposed second tissue contacting member.
The first and second tissue contacting members are operatively
associated with one another and movable between a first
configuration wherein they have a first relative orientation
adapted to receive the tissue therebetween and a second
configuration wherein they have a second relative orientation
adapted to grasp tissue therebetween. The first fluid delivery
conduit has a distal length carried by the first tissue contacting
member and a plurality of outlet ports spaced along that distal
length. The second fluid delivery conduit has a distal length
carried by the second tissue contacting member and a plurality of
outlet ports spaced along that distal length. The outlet ports of
the first and second fluid delivery conduits are oriented generally
inwardly toward one another when the tissue grasping member is in
the second configuration.
A method in accordance with an embodiment of the invention can be
used to create a line of ablated tissue on a hollow organ or vessel
having opposed walls. While this organ may comprise the heart,
other organs or body vessel may be treated with this method, as
well. The opposed walls of the organ are brought closer together,
but not in contact with one another, along a distance within a
plane. Tissue in the opposing walls is ablated along the plane to
form a corresponding line of ablated tissue through the opposed
walls.
A number of embodiments of the invention are particularly well
suited for use in treating cardiac arrhythmias. In certain
embodiments, the invention provides a minimally invasive
alternative for treating atrial fibrillation by delivering a
tissue-damaging agent to selected areas of the heart.
One such embodiment provides a medical device that can be used for,
among other things, treating cardiac arrhythmia. This medical
device includes a reservoir for an injectable tissue-ablating
agent. The device may also include an elongate body adapted for
introduction into a thoracic cavity. The body may have a distal
tissue-contacting member having a length that is flexible and
adapted to conform to a surface of a target tissue. A plurality of
outlet ports is spaced along the tissue-contacting member and a
lumen in the body communicates the fluid supply with the outlet
ports. A pressure control is in fluid communication with the
reservoir and is operable to establish an elevated pressure within
the lumen and propel the tissue-ablating agent from the fluid
supply through the outlet ports to define a plurality of
spaced-apart fluid jets capable of penetrating the target
tissue.
A method of treating cardiac arrhythmia in accordance with a
different embodiment of the invention may include positioning a
tissue grasping member adjacent a target tissue of a heart atrium
or a pulmonary vein. The target tissue has two spaced-apart wall
segments. Opposed tissue-contacting members of the tissue grasping
member may be moved toward one another to deform the target tissue
such that the wall segments are moved closer to, but remain spaced
from, one another. Target tissue in contact with the tissue
contacting members may be ablated to create a lesion extending
through both wall segments.
Still another embodiment of the invention provides a method of at
least partially electrically isolating a pulmonary vein from a
heart atrium having two spaced-apart wall segments. In this method,
the two wall segments are juxtaposed along a first plane. Tissue in
both wall segments is ablated along the first plane with an
ablating member to form a lesion along a first length of each wall
segment. The ablating member may be moved and the two wall segments
may be juxtaposed along a second plane, which may coincide with the
first plane. Tissue in both wall segments is ablated along the
second plane with the ablating member to form a lesion along a
second length of each wall segment, the second length adjoining the
first length.
In an alternative embodiment of the invention for treating cardiac
arrhythmia, a body of an injectate delivery device is guided within
a patient's thoracic cavity to position a distal tissue-contacting
portion of the body in surface contact with a tissue surface of
cardiac tissue. Surface contact between the tissue-contacting
portion and the tissue surface is detected. Thereafter, a
tissue-ablating agent (e.g., an alcohol, hypertonic saline, or
suitably hot or cold saline) is injected into the cardiac tissue
through the tissue-contacting portion of the body. If so desired,
the surface contact may be detected by supplying an excitation
voltage to a plurality of electrodes positioned on the
tissue-contacting portion of the body and measuring a level of at
least one current conducted by the plurality of electrodes. This
level may depend upon a degree of contact between at least two of
the electrodes and the tissue surface.
In accordance with another embodiment, a method of treating atrial
fibrillation includes guiding an elongate, flexible body into
proximity with an exterior tissue surface of a predetermined
portion of a cardiac tissue. An elongate tissue-contacting portion
of the body is brought into surface contact with the tissue
surface. This tissue-contacting portion may include a plurality of
electrodes and a level of at least one current conducted by the
plurality of electrodes may be measured, with the current level
depending on a degree of contact between at least two of the
electrodes and the tissue surface. Thereafter, a tissue-ablating
fluid may be injected into the cardiac tissue through the
tissue-contacting portion of the body, creating a signal-impeding
lesion in the cardiac tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diagram of an embodiment of a catheter apparatus.
FIG. 2 is a diagram of an embodiment of a catheter apparatus.
FIG. 3A is a diagram of the distal end of an embodiment of an
apparatus showing the relative position of the distal end to body
tissue.
FIG. 3B is a diagram of the distal end of an embodiment of an
apparatus showing the relative position of the distal end to body
tissue.
FIG. 3C is a diagram of the distal end of an embodiment of an
apparatus showing the relative position of the distal end to body
tissue.
FIG. 3D is a diagram of the distal end of an embodiment of an
apparatus showing the relative position of the distal end to body
tissue.
FIG. 3E is a diagram of the distal end of an embodiment of an
apparatus showing the relative position of the distal end to body
tissue.
FIG. 4A is an end view of an embodiment of a probe with
sensors.
FIG. 4B is a cross-sectional view of an embodiment of a probe with
sensors.
FIG. 5A is a diagram of an embodiment of a probe with sensors,
showing the relative position of the probe and the sensors to body
tissue.
FIG. 5B is a graph of current as a function of percentage of
contact between sensors and body tissue.
FIG. 6A is an end view of an embodiment of a probe with
sensors.
FIG. 6B is a cross-sectional view of the embodiment of FIG. 6A.
FIG. 7A is an end view of an embodiment of a probe with sensors,
illustrating partial contact between the sensors and body
tissue.
FIG. 7B is a diagram of an embodiment of a display that indicates
partial contact between sensors and body tissue.
FIG. 8A is an end view of an embodiment of a probe with
sensors.
FIG. 8B is a cross-sectional view of an embodiment of a probe with
sensors.
FIG. 8C is a cross-sectional view of an embodiment of a probe with
sensors.
FIG. 9A is a diagram of an embodiment of a probe with sensors
partially intruding into body tissue.
FIG. 9B is a graph of current as a function of percentage of
contact between sensors and body tissue.
FIG. 10A is an end view of an embodiment of a probe with
sensors.
FIG. 10B is a cross-sectional view of an embodiment of a probe with
sensors.
FIG. 11A is a diagram of an embodiment of a probe with sensors
partially intruding into body tissue such that the probe is not
perpendicular to the body tissue surface.
FIG. 11B is a diagram of a display of one embodiment that indicates
the position of the probe with respect to the body tissue surface
and a degree of intrusion into the body tissue.
FIG. 12A is a cross-sectional view of an embodiment of a probe with
a working element and sensors, showing the working element in a
retracted position.
FIG. 12B is a cross-sectional view of an embodiment of a probe with
a working element and sensors, showing the working element in an
extended position.
FIG. 13 is a cross-sectional view of an embodiment of a probe with
a working element and sensors, showing the working element in a
retracted position.
FIG. 14 is a cross-sectional view of an embodiment of a probe with
a working element that is a sensor.
FIG. 15 illustrates a steerable catheter-type device for delivering
selected diagnostic and/or therapeutic agents to target sites
within a selected body tissue using high-energy jets, in accordance
with an embodiment of the present invention.
FIG. 16A is an enlarged, side-sectional view of a distal-end region
of the device shown in FIG. 15.
FIG. 16B shows the device of FIGS. 15 and 16A being used to direct
four high-energy jets carrying one or more selected therapeutic
and/or diagnostic agents through a wall of a selected body organ
and into the tissue.
FIG. 17 is an exploded view of the apparatus of FIGS. 16A B.
FIG. 18 is a partial, side-sectional view of a further embodiment
of an agent-delivery apparatus for delivering selected diagnostic
and/or therapeutic agents to target sites within a selected body
tissue using high-energy jets, according to the teachings of the
present invention.
FIG. 19 shows the distal-end region of a steerable catheter-type
device for delivering selected diagnostic and/or therapeutic agents
to target sites within a selected body tissue using ultrasonic
energy, according to one embodiment of the present invention.
FIG. 20A shows, in partial side-sectional view, an exemplary
agent-delivery port and a secondary drug or gas port that meets the
delivery port at an angle.
FIG. 20B-C schematically illustrates exemplary jet or spray
patterns which may be achieved using the apparatus of FIG. 20A.
FIG. 21 is a partial side view, with portions shown in section, of
an exemplary valving mechanism operable to regulate fluid flow
through an agent-delivery lumen and/or outlet port.
FIG. 22 shows a portion of a steerable catheter positioned with its
distal end adjacent a target region of an endocardial wall of a
patient's left ventricle, with the catheter being adapted to
maintain its distal end at such position notwithstanding
"action-reaction" forces due to high-energy jets emanating
therefrom that would tend to push it away from the wall.
FIG. 23A-D are partial side view of an example of the invention as
it is placed near a tissue (23A), urged against the tissue (23B)
thus creating a contact force between the device and the tissue,
the application of hydraulic force causing ejection of a fluid
stream from each outlet port thus propelling the fluid into the
tissue (23C), and the removal of hydraulic force and the retention
of fluid by the tissue within pockets created by hydraulic erosion
(23D).
FIG. 24A illustrates an example of the invention where the device
is conveyed to the target tissue via a steerable catheter with
having an axial lumen where the device is slidably directed towards
the target tissue.
FIG. 25 illustrates an example of the invention where the device is
combined with a steerable catheter in one structure.
FIG. 26 illustrates an example of the invention where the device is
combined with a first steerable catheter in one structure which
resides in a second steerable catheter having an axial lumen where
the first steerable catheter is slidably maintained.
FIG. 27A is an end view of an injection device incorporating tissue
contact sensors.
FIG. 27B is a cross-sectional view of the injection device of FIG.
27A.
FIGS. 28A C are top, lateral and front views, respectively, of a
tissue treatment device in accordance with still another embodiment
of the invention having a flexible tissue-contacting member.
FIGS. 29 32 are top views of tissue treatment devices having
tissue-contacting members in accordance with other embodiments of
the invention.
FIG. 33 is a top view of another embodiment of a tissue treatment
device.
FIG. 34 is a partial side view of the tissue treatment device of
FIG. 33 taken along line 34--34 in FIG. 33.
FIG. 35 is a schematic cross sectional view of the tissue treatment
device of FIGS. 33 34 taken along line 35--35 in FIG. 34.
FIG. 36 is a schematic illustration of the device of FIG. 33 being
used to treat tissue of a pulmonary vein.
FIG. 37A is a side view of a tissue treatment device in accordance
with still another embodiment of the invention.
FIG. 37B is a side view of a modified version of the embodiment of
FIG. 37A.
FIGS. 38A and 38B are isolation views of a distal portion of the
tissue treatment device of FIG. 37A in an open configuration and in
a closed configuration, respectively.
FIGS. 39A and 39B are isolation views of an alternative distal
portion, useful in the tissue treatment device of FIG. 37A, in an
open configuration and in a closed configuration, respectively.
FIG. 40 is a side view of a tissue treatment device in accordance
with still another embodiment of the invention.
FIG. 41 schematically illustrates positioning of the tissue
treatment device of FIG. 33 adjacent to a patient's heart to treat
atrial fibrillation.
FIG. 42 is a close-up view schematically illustrating a step in a
process of forming a lesion around a pulmonary vein.
FIG. 43 schematically illustrates the lesion formed in the process
illustrated in FIG. 42.
FIG. 44 schematically illustrates positioning of an alternative
tissue treatment device with respect to two pulmonary veins.
FIG. 45 schematically illustrates the lesion formed in the process
illustrated in FIG. 44.
DETAILED DESCRIPTION
Various embodiments of the present invention provide medical
devices that can be used in a wide range of applications and
several methods that can be used for, among other things, treating
cardiac arrhythmia. The following description provides specific
details of certain embodiments of the invention illustrated in the
drawings to provide a thorough understanding of those embodiments.
It should be recognized, however, that the present invention can be
reflected in additional embodiments and the invention may be
practiced without some of the details in the following description.
In the following discussion, embodiments of the invention employing
tissue contact sensors are discussed first, followed by embodiments
including needles, embodiments providing for needleless injection,
and treatment methods in accordance with embodiments of the
invention.
Embodiments Including Tissue Contact Sensor(s)
Certain embodiments of the invention provide medical apparatus
including sensors that accurately indicate the position of the
apparatus in relation to body tissue. The sensors may provide this
indication without secondary sources of information, such as
previously developed maps of body regions. In certain embodiments,
the sensors that provide the position information further provide
physiological information. The sensor or sensors may be placed on
various locations on the catheter shaft and on the distal tip,
depending on the application and desired information required for
the surgical or diagnostic procedure. In one embodiment, the
sensors are electrodes that indicate a degree of contact between
the apparatus and a tissue surface, and also indicate an
orientation of the apparatus with respect to the tissue surface.
The sensors further transmit an EKG signal from the body tissue.
The indication of the degree of contact includes a pressure
indication, or an indication of the degree the apparatus intrudes
into the body tissue. In one embodiment, a working element includes
a sensor. For example, in one embodiment, the working element is a
needle that delivers a drug and also transmits an EKG signal such
that the condition of the tissue is monitored before and after the
drug is delivered. In one embodiment, the apparatus includes a
catheter with sensors on a distal probe for positioning the distal
probe, and a working element with a sensor disposed in a lumen of
the catheter.
FIG. 1 is a diagram of an embodiment of an apparatus 14 for guided
interventional procedures. The apparatus 14 includes an assembly 16
for accessing a body tissue surface 18 inside a patient's body, and
an actuator 24. The actuator 24 is attached to the assembly 16 in
such a way as to steer the assembly 16 by one of several known
methods. A distal end probe 22 is placed in contact with the tissue
surface 18 in order to perform an interventional procedure. Sensors
(not shown in the figure) in the distal probe 22 are electrically
connected to a control unit 28. The control unit 28 includes a
power source for supplying voltage across the sensors, and
circuitry for receiving and processing signals. For example, the
control unit 28 includes circuitry for detecting and measuring
current levels across the sensors.
The control unit 28 is connected to an activator 30 and a display
32. The control unit 28 is further connected to the actuator 24. In
one embodiment, the actuator 24 is automatically controlled
depending upon signals received from the sensors by the control
unit 28. For example, the actuator 24 is directed to move the
distal end probe or to stop moving the distal end probe 22
dependent upon a predetermined relative position of the distal end
probe 22 with respect to the tissue surface 18. The display 32
displays information about the relative position, such as the angle
of the distal end probe 22 with respect to the tissue surface 18
and the degree of intrusion of the distal end probe 22 into the
tissue surface 18. In one embodiment, the display 32 further
presents EKG information.
In one embodiment, the assembly 16 is a known steerable catheter
assembly. In one application, the assembly 16 is used to access an
internal target tissue region, and to provide a therapeutic
stimulus. The therapeutic stimulus can be any of several known
stimuli, such as injection of a therapeutic compound, cells, or
gene, forming a laser channel, or introducing an injury on or below
the surface of the target region. Ultrasonic waves, infrared
radiation, electromagnetic radiation, or mechanical means, for
example, can introduce the injury. In one embodiment useful for
treatment of atrial fibrillation, an ablative agent or other
tissue-damaging fluid may be injected through and/or below the
surface of the target tissue. The therapeutic stimulus may be
administered/provided through the distal end probe 22.
In one embodiment, the assembly 16 is sized to be manipulated
through the vasculature of a patient until the distal end probe 22
is proximate a surface or wall region of a selected tissue or
organ. For example, the distal end probe 22 may be placed within
about 5 mm of a tissue surface within a heart chamber, such as the
heart endocardial wall within the left ventricle.
In embodiments used for procedures that include injecting a
compound or gene into tissue, the actuator 24 includes a drug
delivery module. The drug can be delivered by a needle or by a
needleless injection mechanism in the distal end probe 22.
In various embodiments, the assembly 16 is an endoscopic device
having a distal end probe and a distal end working element (not
shown) for introducing or providing a therapeutic effect at or
adjacent an organ or tissue target site. Also contemplated is a
rigid accessing tool (not shown) that includes an elongate rod that
can be guided through an incision, such as in the chest wall, for
placement of a distal end probe carried on the rod against the
surface of the target tissue.
FIG. 2 is a diagram of an embodiment of an apparatus 15 for guided
interventional procedures that includes separate display devices
for position information and for physiological information. The
apparatus 15 includes the assembly 16 and the actuator 24. The
apparatus further includes the control unit 28 and the activator
30. The display 37 displays position information from sensors as
described below. The display 39 displays EKG information. In one
embodiment, the display 39 is a commercially available EKG monitor.
In one embodiment, the display 37 and the display 39 receive the
same signal and filter out unneeded signal components. In one
embodiment, the signal is one or more current levels from electrode
sensors, as described below.
FIG. 3A is a diagram showing the distal end probe 22 and the tissue
surface 18. The tissue surface 18 is part of a target region of
cardiac tissue 34, e.g., a heart interior wall or exterior wall. A
heart-wall trabecula 38 is also shown. Heart-wall trabeculae are
typically about 2 3 mm in diameter and have a depth of 1.5 to 2 mm.
As an example of an application, the target region can be a hypoxic
region identified as lacking sufficient oxygen, presumably due to
poor vascularization in the region. The therapeutic objective is to
stimulate angiogenesis in the hypoxic region by introducing an
angiogenic agent and/or by stimulating the tissue with an
angiogenic injury. The tissue surface 18 in this example may
comprise part of a heart chamber wall. The heart chamber may be
filled with blood in contact with the tissue surface 18. A second
example is the injection of cells for tissue regeneration in an
infarcted region of the heart. In accordance with another
embodiment useful in treating cardiac arrhythmia, particularly
atrial fibrillation, the cardiac tissue 34 shown in FIGS. 3A E may
comprise a portion of an atrial wall. For example, the cardiac
tissue 34 may be located adjacent a pulmonary vein such that
forming a cardiac lesion at the site could help electrically
isolate a pulmonary vein.
The sensors and the control unit (neither of which are shown in
FIG. 3) can be used to detect that the distal end probe 22 probe is
properly placed with respect to the tissue surface when the therapy
is delivered. Optimal placement of distal end probe 22 has several
components. For example, the distal face of the distal end probe
may be in contact with, or very close to, the tissue surface 18 in
the target region receiving the treatment to more effectively
control the level of therapeutic stimulus being delivered. FIG. 3A
illustrates a situation in which the distal end probe 22 is in the
chamber but not in contact with the heart wall 34. In many methods
of the invention, the therapeutic stimulus should not be applied in
this situation.
FIG. 3B illustrates the angle of contact a between the distal end
probe 22 and the tissue surface 18. This is another component of
optimal distal end probe 22 placement. The angle of contact a
should be within a desired range, e.g., no more than 10.degree.
30.degree., with respect to an axis 40 that is normal to the tissue
surface 18. Typically, as the angle a increases, the distal end
probe 22 is less in contact with the tissue surface 18, and
consequently the therapeutic stimulus is distributed over a wider
area rather than being concentrated in the target region. If the
therapeutic stimulus comprises a tissue-damaging agent for use in
creating lesions to treat cardiac arrhythmia, for example,
dispersing the agent over a wider or less precisely controlled area
may lead to collateral tissue damage.
Optimal placement of the distal end probe 22 can be complicated by
the presence of trabecula 38 or other irregularities on the heart
wall 34, as illustrated in FIG. 3C. FIG. 3C shows initial contact
of the probe with trabecula 38, which is essentially a recessed
area in the target region. In this case, the distal end probe 22
makes contact with the target region, and even intrudes into the
target region, but contact between the distal face of the distal
end probe 22 and the tissue surface 18 is limited. As will be
explained below, this limited contact may be detected and avoided
using embodiments of the apparatus 14.
FIG. 3D illustrates a surface contact condition between the distal
end probe 22 and the tissue surface 18 that is optimal for certain
procedures. In this illustrated condition, the longitudinal axis of
the distal end probe 22 is substantially perpendicular to the plane
of the tissue surface 18. For some procedures to be most effective,
the distal end probe 22 should be applied to the tissue surface 18
with a force that is within a predetermined optimal range.
The depth of intrusion of the distal end probe 22 into the tissue
surface 18 is another factor that can effect optimal distal end
probe 22 placement. FIG. 3E shows the distal end probe 22 intruding
into the tissue surface 18 in the target region. The tissue surface
18 in the target region is distorted as a result. In addition, the
thickness of the heart wall is reduced locally. The tissue
distortion may adversely affect the application of the stimulus,
and the reduced tissue thickness may lead to suboptimal targeting
of the stimulus.
Achieving a desired contact angle and contact force is further
complicated in the heart by the beating of the heart. In one
embodiment (not shown), the heart wall movement is compensated for
by a mechanism near the distal end probe 22 that accommodates
movement in multiple axes with little change in contact angle and
pressure. In other embodiments, the distal end probe is flexible so
as to allow movement in multiple axes. In various embodiments, the
procedure includes timing the delivery of the therapy to coincide
with a defined period of the cardiac cycle when optimal contact
occurs.
FIG. 4A is an end view of an embodiment of a distal end probe 42
that allows surface contact between the distal end probe 42 and a
tissue surface to be sensed during a procedure. The distal end
probe 42 includes a lumen 44 through which a therapeutic stimulus
can be administered. A planar front face 46 may be placed in
contact with the target tissue when the stimulus is administered.
Inner and outer annular electrodes, or sensors, 48 and 50,
respectively, surround the lumen 44 and are separated by insulators
52, 54, and 56. In one embodiment, the electrodes 48 and 50 are
formed of gold, silver, or another conductive material, and are
formed on the probe face by plating or attachment methods.
In describing the operation of the electrodes, it is useful to
consider each electrode as being made up of multiple electrode
surface elements, such as electrode elements 62 in electrode 48 and
corresponding electrode elements 64 in electrode 50. The electrode
elements have arbitrarily defined sizes and positions on their
respective electrodes. Current paths exist between electrode
elements of electrode 48 and corresponding electrode elements of
electrode 50. Referring to FIG. 4B, current paths between
corresponding electrode elements 62 and 64 are indicated at 66.
Each such current path represents a path current flow between
corresponding electrode elements of electrodes 48 and 50. Current
flows along the current paths 66 when a voltage potential is
applied across the electrodes 48 and 50, and corresponding
electrode elements are electrically connected.
In certain applications, corresponding electrode elements of
electrodes 48 and 50 are electrically connected when immersed in an
electrolytic medium, such as blood. When the electrode elements are
electrically connected by the medium, there is maximum current
flow. When an electrode element is in contact with a tissue
surface, the current path between the electrode elements passes
through the tissue surface, which may have a much higher
resistance. By monitoring the current between electrode elements 48
and 50, the electrodes may be employed as sensors to detect contact
between the distal end probe 42 and the tissue surface.
In various embodiments, the electrodes 48 and 50 are electrically
connected to circuitry, such as that described with reference to
the control unit 28 of FIG. 1, through conductors 58 and 60. The
circuitry measures the extent to which the current paths between
corresponding electrode elements are blocked or enabled by
measuring total current flow across the electrodes 48 and 50 when a
voltage is applied across the electrodes 48 and 50.
FIG. 5A is a diagram showing the distal end probe 22 in partial
contact with the tissue surface 18. Inner electrode 48 and outer
electrode 50 are also shown schematically. When the distal end
probe 22 contacts the tissue surface 18 at an angle other than
90.degree., as shown in FIG. 5A, the electrode elements in contact
with the tissue surface will conduct relatively little current
while the exposed electrode elements may remain in contact with a
more conductive medium, such as blood. The relationship between the
percentage of the probe face 46 in contact with the tissue surface
and the current through the electrode elements is shown in FIG. 5B.
Little or no contact results in maximum current. The amount of
current decreases in the manner shown until complete or
substantially complete contact is achieved, thus providing an
indication of the amount of contact between the distal end probe 22
and the tissue surface.
When the distal end probe is guided into place transvascularly, the
blood will provide a conductive path between the electrodes 48 and
50 and the tissue will provide a relatively less conductive path.
In other embodiments of the invention, however, blood may not
provide a consistent conductive medium between the electrodes 48
and 50 prior to contact with the tissue. For example, if the distal
end probe 22 is introduced into a relatively dry field, such as the
thoracic cavity via an intercostal incision, little or no current
will be conducted between the electrodes 48 and 50 prior to
contacting the patient's tissue. When the patient's tissue is
contacted, however, the relatively moist tissue surface may provide
sufficient conductivity to establish a detectable increase in
current between the electrodes 48 and 50. Again, the increase in
detected current may be proportional to the surface area of the
electrodes 48 and 50 in contact with the target tissue surface, but
with current increasing with increasing tissue contact in this
circumstance. By appropriate modification of the circuitry in the
control unit 28 (FIG. 1), the electrodes 48 and 50 can, therefore,
be adapted to detect tissue contact as reflected in a drop in
current or an increase in current.
In one embodiment of the distal end probe 22, one or more of the
electrodes 48 and 50 function as physiological sensors. In one
embodiment, the physiological sensors are EKG sensors. The
electrodes 48 and 50 transmit EKG data to a control unit, such as
the control unit 28 in FIG. 1, via the conductors 58 and 60. The
EKG data is processed and displayed. The availability of EKG
information with position information during a procedure has
several advantages. For example, the position information provides
a precise origin of the EKG information. In addition, when a
therapeutic agent is introduced into a target region of tissue, the
change in the tissue can be observed in real-time through the EKG.
The EKG information assists the user in assessing the health of
tissue in a prospective target region. For example, a user may
discard a previously chosen target region for injecting an
angiogenic agent because the EKG information indicates the tissue
in the region is infarcted. Conversely, the user can check the EKG
information when the distal end probe has been positioned and
deliver the therapeutic agent if the condition of the tissue is
satisfactory per the EKG information.
FIG. 6A is an end view of an embodiment of a distal end probe 68
that allows the quality of contact between the distal end probe 68
and a tissue surface to be sensed. The quality of contact includes
degree of contact and the angle between the longitudinal axis of
the distal end probe 68 and the tissue surface. The distal end
probe 68 includes a lumen 71. A probe face 70 (shown in FIG. 6B) of
the distal end probe 68 includes an outer annular electrode, or
sensor, 74, and an inner annular electrode, or sensor, 72 that
includes multiple electrode sections 72a, 72b, 72c, and 72d. The
insulators 78 and 76 separate the electrodes 72 and 74. The
insulator 76 further separates the sections of the electrode 72
from each other.
As shown in the cross-sectional view of FIG. 6B, the electrodes 72
and 74 are electrically connected to circuitry, such as that
described with reference to the control unit 28 of FIG. 1, through
conductors 80, 82, and 84. The coupling 80 is connected to the
electrode 74. Each of the electrodes 72a, 72b, 72c, and 72d are
connected to a different coupling, only two of which (82 and 84)
are shown.
Through the conductors 80, 82, and 84, voltages are applied
separately to each of the electrodes 72 and to electrode 74.
Current may flow best between the electrodes 74 and 72 in the areas
that are not in contact with tissue. FIG. 7A illustrates a case in
which the distal end probe 68 is in partial contact with a tissue
surface such that there is an angle of less than 90.degree. between
the longitudinal axis of the distal end probe 68 and the tissue
surface. The shaded regions of the electrodes 72 indicate contact
with the tissue surface. In this case, there is complete contact
between the lower portion (in the figure) of the planar probe face
71 and the tissue surface. There is also partial contact between
the right and left sides (in the figure) of the probe face 71 and
the tissue surface.
FIG. 7B is a diagram of an embodiment of a display 86. The display
86 indicates the angle and degree of contact corresponding to the
current flow as shown in FIG. 7A. Indicators 85 are typical of the
17 indicators that are arranged in two lines that intersect at an
indicator 87 as shown. The indicators 85 are arranged to suggest
the manner in which the plurality of sensors is arranged on the
distal end probe 68. The arrangement of the indicators generally
corresponds to locations on the probe face 71. A shaded indicator
85 indicates contact between the probe face 71 and the tissue
surface at the location of the shaded indicator. An unshaded
indicator 85 indicates no contact between the probe face 71 and the
tissue surface at the location of the unshaded indicator. In one
embodiment, the indicators are lights, such as light emitting
diodes (LEDs), and are lit when a corresponding electrode is in
contact with tissue. The display 86 allows a user to quickly assess
angle and degree of contact between the probe face 71 and the
tissue surface.
In one embodiment of the distal end probe 68, one or more of the
electrodes 72 and 74 function as physiological sensors. In one
embodiment, the physiological sensors are EKG sensors. The
electrodes 72 and 74 transmit EKG data to a control unit, such as
the control unit 28 in FIG. 1, via the conductors 80, 82, 84, etc.
The EKG data is processed and displayed.
FIGS. 8A 8C are diagrams of an embodiment of a distal end probe 88
that facilitates a determination of the angle of contact between
the probe face 92 and a tissue surface. The distal end probe 88
further facilitates a determination of a degree to which the distal
end probe 88 intrudes into the tissue surface. The probe face 92 is
rounded, as seen in cross-section in FIG. 8B. Annular electrodes,
or sensors, 94, 96, and 98 are arranged at increasing radii about a
lumen 93. Insulators 100, 102, 104, and 106 separate the electrodes
94, 96, and 98. The electrodes 94, 96, and 98 are electrically
connected to connected to circuitry, such as that described with
reference to the control unit 28 of FIG. 1, through conductors 108,
110, and 112. Voltages are separately applied to each of the
electrodes 94, 96, and electrode 98 through the respective
conductors 108, 110, and 112, creating a current flow in proportion
to amount and location of contact between the electrodes and the
tissue surface.
FIG. 8C is a diagram of an alternative electrode configuration. The
distal end probe 89 includes a lumen 91. An inner annular electrode
95 substantially covers the rounded face of the distal end probe
89. The inner annular electrode 95 is separated from an outer
annular electrode 99 by an insulator 97. The electrodes 95 and 97
are electrically connected to circuitry, such as that described
with reference to the control unit 28 of FIG. 1, through conductors
101 and 103.
FIGS. 9A and 9B illustrate an example of one application for the
distal end probe 88 and the information provided by the electrodes
94, 96, and 98. FIG. 9A shows the distal end probe in contact with
the tissue surface 18. The distal end probe 88 intrudes into the
tissue surface 18 such that the electrode 94 is in contact with the
tissue surface 18, but the electrodes 96 and 98 are not in contact.
FIG. 9B shows two graphs that each plot current as a function of
degree of contact between an electrode and the tissue surface 18.
The curve 112 shows the plot for the distal end probe intruding
into the tissue surface 18 to distance d1. The curve 114 shows the
plot for the distal end probe intruding into the tissue surface 18
to distance d2. Distances d1 and d2 are illustrated in FIG. 8B.
The current levels on the plots for d1 and d2 vary depending on the
angle of contact and depth of intrusion of the distal end probe 18.
For example, an optimal contact would give a low current level at
d.sub.1, indicating a good contact angle, and a high level at
d.sub.2, indicating a desired depth of intrusion. Various current
levels can indicate a contact angle that is not close enough to
90.degree. and/or a level of tissue intrusion that is too high or
too low.
FIGS. 10A and 10B illustrate an embodiment of a distal end probe
116 that allows the user to obtain information about the angle of
contact of the distal end probe 116 with the tissue, and the depth
of intrusion into the tissue. The distal end probe 116, as shown in
FIG. 10A, includes electrodes, or sensors, 120, 122, and 124. Each
of the electrodes 120, 122, and 124 are annular and arranged
concentrically about the longitudinal axis of the distal end probe
116. Each of the electrodes 122, 124, and 126 are divided into four
electrode sections (labeled a, b, c, and d) that are each
electrically insulated from any other electrode section by an
insulating material, indicated by shading.
The distal end probe 116, as shown in FIG. 10B, has a rounded probe
face 118 that includes the electrodes 120, 122, and 124 at
distances d.sub.1, d.sub.2, and d.sub.3, respectively, from the
distal end of the distal end probe 118. Each of the sections a, b,
c, and d of the electrodes 120, 122, and 124 are electrically
connected to circuitry, such as that described with reference to
the control unit 28 of FIG. 1, through conductors. For example, the
coupling 128b is connected to the electrode section 124b, the
coupling 126b is connected to the electrode section 120b, and the
coupling 126a is connected to the electrode section 120a.
FIG. 11A illustrates the distal end probe 116 in contact with the
tissue surface 18 such that the electrodes, or sensors, 120, 122,
and 124 are partially in contact with the tissue surface 18,
including partial intrusion into the tissue surface 18. FIG. 11B is
an embodiment of a display with four groups of indicators. The
indicators are arranged to suggest the manner in which the
plurality of sensors is arranged on the distal end probe 116. The
arrangement of the indicators generally corresponds to locations
about the distal end probe 116. Each of the indicators is similar
to exemplary indicators 122 and 124. Indicators 122 are shaded to
indicate contact between the distal end probe 116 and the tissue
surface 18. Indicators 124 are not shaded to indicate no contact
between the distal end probe 116 and the tissue surface 18. In one
embodiment, the indicators are lights, such as light emitting
diodes (LEDs), and are lit when a corresponding electrode is in
contact with tissue. Within each of the four groups of indicators,
four indicators are in a line with a central indicator 125,
indicated as lines 1. These indicators indicate the current flow
through electrode sections at probe depth d.sub.1 thus indicating
contact at depth d1. The four indicators in lines 2 indicate the
current flow through electrode sections at depth d2. The next four
indicators in lines 3 indicate the current flow through electrode
sections at depth d.sub.3. The display pattern in FIG. 11B
indicates that the electrode sections at all three depths at an
arbitrarily designated "lower" portion of the distal end probe 116
are in contact with the tissue surface, as shown by the shaded
indicators. The inner electrode sections on two "sides" of the
distal end probe 116 adjacent the lower portion are also in contact
with the tissue surface. The "upper" electrode sections are not in
contact with the tissue, as indicated by unshaded indicators. This
display reflects the contact situation shown in FIG. 11A.
The information displayed as in FIGS. 5B, 7B, 9B, and 11B can be
used to determine when to deliver a drug, or some other therapy, to
the tissue through the distal end probe. As discussed in more
detail below, in certain embodiments of the invention, an injectate
is injected into the patent's tissue only after appropriate surface
contact between the medical device and the tissue has been
detected.
In one embodiment of the distal end probe 116, one or more of the
electrodes 120, 122, and 124 function as physiological sensors. In
one embodiment, the physiological sensors are EKG sensors. The
electrodes 120, 122, and 124 transmit EKG data to a control unit,
such as the control unit 28 in FIG. 1, via the conductors 128b,
126a, 126b, etc. The EKG data is processed and displayed.
Referring to control unit 28 of FIG. 1, in one embodiment, the
control unit 28 further controls the delivery of a drug or therapy
when an appropriate position of the distal end probe with respect
to the tissue surface has been achieved. In one embodiment, the
activator 30 receives data from the control unit 28, and sends an
activation signal to the actuator 24 when the data indicates that
the appropriate position of the distal end probe with respect to
the tissue surface has been achieved. The activator 30 is
programmable to send the activation signal under specified
conditions, including specified distance from tissue, specified
degree of contact with tissue, specified angle of contact with
tissue and specified degree of intrusion into tissue. In one
embodiment, the activator 30 further includes circuitry for guiding
the position of the distal end probe via the actuator 24 until a
desired contact position is achieved.
Embodiments Employing Needles
FIGS. 12A, 12B, and 13 illustrate embodiments of distal end probe
assemblies for delivering a therapeutic stimulus to tissue. FIG.
12A is a cross-sectional view of a distal end probe 130 that has a
rounded contact surface with a central lumen 132 through which a
needle 134 can be extended. In one embodiment, a therapeutic
solution is administered from a reservoir in the actuator 24 (FIG.
1) into the target tissue through a lumen (not shown) of the needle
134. The distal end probe 130 includes electrodes, or sensors, 136,
138, and 140. The electrodes serve as sensors as previously
described with reference to other embodiments, and communicate with
a control unit, as previously described, through conductors 142,
144, and 146.
In FIG. 12A, the distal end probe 130 is in a deployment
configuration with the needle 134 in a retracted position wherein
the distal end of the needle is received within the lumen 132 of
the distal end probe 130. The needle 134 may be axially slidable in
the lumen 132 of the distal end probe 130. An operator may control
movement of the needle 134 along the lumen 132 manually, under
control of a control unit (28 in FIG. 1), or through any other
means known in the art. FIG. 12B shows the distal end probe 130 in
a treatment configuration with the needle 134 advanced distally
into an extended position. In one embodiment, the needle 134 may be
advanced after the sensors 136 140 detect surface contact with a
patient's tissue. This will advance the needle 134 into the tissue,
facilitating delivery of a therapeutic stimulus, e.g., injection of
a tissue-damaging agent to create a cardiac lesion in treating
atrial fibrillation.
In various other embodiments, working elements other than needles
may be employed. The working element can retract into the distal
end probe in the lumen, or can be fixed in a position. Various
working elements can be used to perform various therapeutic and
diagnostic procedures. For example, FIG. 13 is a cross-sectional
diagram of a distal end probe 150 that includes an optical fiber
154 in a central lumen. The optical fiber 154 delivers a pulse of
laser light as a therapeutic stimulus. In another example, needle
134 acts as an RF electrode causing localized thermal injury in the
tissue surrounding the needle.
In one embodiment, a distal end probe such as 130 or 150 is
maneuvered, e.g., at the tip of a catheter, to a selected target
site. During this maneuvering, the user may track the probe
fluoroscopically, according to known methods. When the probe is at
or near the target site, the user views a display, such as the ones
previously described, to determine the angle of contact and/or
depth of contact between the distal end probe and the tissue
surface, and also to monitor physiological data. The user continues
to position the distal end probe until the desired position is
achieved. For example, if the distal end probe encounters a
trabecula, attempts to improve the contact area by rotating the
catheter shaft or adjusting the axial force applied to the shaft
may not significantly improve the indicated degree of contact. In
this case, the user may simply move the probe to another region and
attempt to position the distal end probe again. The user may also
select a site and position based on the physiological data, such as
EKG data.
FIG. 14 is a diagram of an embodiment including a distal end probe
160 and a working element 162 in a lumen 164. The working element
162 may be a needle for delivering a drug, cells, or creating an
injury using mechanical or other means. In other embodiments, the
working element can be any one of any of a variety of working
elements used in conjunction with catheters to perform various
medical procedures. The distal end probe 160 includes electrodes,
or sensors, 168, 170, and 172. The electrodes 168, 170, and 172
function similarly to the electrodes 136, 138, and 140 described
with reference to FIG. 12A. The working element 162 is connected to
the coupling 174, which transmits physiological data collected by
the working element 162 from tissue the working element is in
contact with. In one embodiment, the physiological data is EKG
data. The availability of the EKG information from the working
element 162 along with the position and/or EKG information from the
electrodes 168, 170, and 172 is very useful for obtaining very
site-specific information about tissue during a procedure. For
example, in the case of non-transmural infarcts, an infarcted area
can be isolated between the endocardium and the epicardium. As the
working element progresses through the tissue, the EKG signal from
the working element gives an accurate indication of relative tissue
health at the site of the working element. Thus, information that
is not available from the tissue surface becomes available. There
may be no electrical activity on the endocardium, but as the
working element is advanced through the tissue, electrical activity
may be detected closer to the epicardium. Hence, a therapeutic
agent may be delivered through a needle 162 to treat tissue and the
same needle 162 can be used to monitor physiological data
pertaining to the tissue as it is being treated.
FIGS. 12 14 illustrate embodiments employing a single needle. It
should be understood that the invention may be practiced with a
plurality of needles. The needles may communicate with a common
reservoir of injectate, or may be used to deliver different
injectates. If the needles are retractable during deployment, they
may be deployed individually or with a common deployment mechanism.
If multiple needles are employed, they need not all be oriented for
deployment distally from a distal end of the injectate delivery
device. For example, they may be spaced along a length of an
elongate tissue-contacting member (e.g., member 434 of FIG. 29 or
member 454 of FIG. 30) adapted to position the needles in close
proximity to the surface of the target tissue prior to
deployment.
Embodiments Employing Needleless Injection
FIG. 15 illustrates a catheter assembly, indicated generally by the
reference numeral 212, in accordance with another embodiment of the
invention. The catheter assembly 212 (or even just selected aspects
thereof) can be used instead of the apparatus 14 or 15 of FIGS. 1
and 2, respectively, (or selected aspects thereof) in the
embodiments discussed above. Likewise, aspects of the apparatus 14
and 15 may be used in conjunction with the catheter assembly 212
and other embodiments discussed below.
The catheter assembly 212 of FIG. 15 includes a hand unit 214
attached to a steerable catheter shaft or jacket 216 having a
controllably deflectable distal-end portion, as at 216a. Steering
of the catheter assembly can be accomplished in a variety of ways.
For example, the catheter assembly can include steering components
like those disclosed in U.S. Pat. No. 5,876,373, entitled
"Steerable Catheter," to Giba et al.; and/or in U.S. Pat. No.
6,182,444, entitled, "Drug Delivery Module," to Glines et al.;
and/or in published European Patent Application No. EP 0 908 194
A2; each of which is incorporated entirely herein by reference. In
one exemplary arrangement, a conventional pull wire (not shown) is
secured at a distal tip of the jacket and extends through a
wire-guide channel, formed longitudinally through a sidewall of the
jacket, to the hand unit, whereat the wire's proximal end is
coupled to a deflection or steering actuator assembly. Rotation of
a deflection knob, such as 220, which is threadedly mounted along a
forward end of the hand unit, causes the pull wire to be pulled
backward, and/or the jacket to be pushed forward, relative to one
another, thereby inducing deflection of the distal end of the
jacket. Rather than running the pull wire through a channel
extending through a sidewall of the jacket, another embodiment
provides the pull wire extending longitudinally along an interior
sidewall of the jacket. An advantage of the steerable catheter
embodiment of the present embodiment over Giba's steerable catheter
is the omission of the third inner tool, housed within the second,
steerable catheter of Giba. Embodiments of the present invention
provide for a unified structure of the tool and steerable catheter
making the device simpler, more easily operated, and less costly to
manufacture than Giba's triaxial, or coaxial arrangement. Another
embodiment of the invention provides for a single catheter unified
system where the jet device is integrated into a steerable catheter
and omitting the outer, non-steering sheath catheter of Giba,
discussed above. Alternatively, the inner tool or fiber optic of
Giba may be omitted resulting in a steerable catheter slidably
housed within an outer sheath. Other navigation mechanisms and
arrangements, suitable for use herein, will be apparent to those
skilled in the art. For example, the catheter shaft or jacket can
be configured with a fixed shape (e.g., a bend) at its distal end
to facilitate navigation as described in application Ser. No.
08/646,856 by Payne filed May 8, 1996, entirely incorporated by
reference herein. Another embodiment of the present invention
provides for an arrangement that includes a dual steering mechanism
where both the inner and outer catheter are steerable with either
or both catheters steering as a result of either or both having a
pull wire or a pre-shaped member. FIG. 25 illustrates a double
steerable catheter device 1100, having a first outer steerable
catheter 1102 slidably housing a second inner catheter 1104 having
a jet discharge tip 1106 located on its distal end 1108.
Jacket 216 is dimensioned to be placed in the vasculature of a
subject and navigated therethrough until the distal tip is disposed
proximate a surface or wall region of a selected tissue or organ,
e.g., within about 5 mm from a surface within a heart chamber (such
as the endocardial wall within the heart's left ventricle). The
outer diameter of the catheter jacket is not critical, provided
only that it can be navigated to a desired site within a subject
body. Suitable catheter jackets range in size, for example, from
about 3 French to about 9 French. One preferred catheter jacket is
7 French. Suitable catheter jackets are available commercially, for
example as guiding catheters and diagnostic catheters from Bard
Cardiology, Cordis, and Schneider Worldwide. Certain preferred
jackets from such sources include fixed shapes at their distal end,
instead of pull-wire steering mechanisms.
Visualization enhancement aids, including but not limited to
radiopaque markers, tantalum and/or platinum bands, foils, and/or
strips may be placed on the various components of the catheter
assembly, including on the deflectable end portion 216a of catheter
jacket 216. In one embodiment, for example, a radiopaque marker
(not shown) made of platinum or other suitable radiopaque material
is disposed adjacent the distal tip for visualization via
fluoroscopy or other methods. In addition, or as an alternative,
one or more ultrasonic transducers can be mounted on the catheter
jacket at or near its distal tip to assist in determining its
location and/or placement (e.g., degree of perpendicularity) with
respect to a selected tissue in a subject, as well as to sense
proximity with, and/or wall thickness of, the tissue. Ultrasonic
transducer assemblies, and methods of using the same, are
disclosed, for example, in published Canadian Patent Application
No. 2,236,958, entitled, "Ultrasound Device for Axial Ranging," to
Zanelli et al., and in U.S. Pat. No. 6,024,703, entitled,
"Ultrasound Device for Axial Ranging," to Zanelli et al., each of
which is incorporated entirely herein by reference. In one
embodiment, for example, two transducers are angle mounted at the
distal tip of the catheter shaft in the axis or plane of pull-wire
deflection. This construction permits an operator to determine, by
comparing signal strength, whether the catheter tip region is
perpendicular to a selected tissue surface or wall. Additionally,
this two-transducer arrangement provides an operator with
information useful for determining an appropriate adjustment
direction for improving perpendicularity, as compared to
single-transducer arrangements that, while capable of indicating
perpendicularity by signal strength amplitude, are generally
incapable of indicating a suitable direction in which to move the
tip to improve perpendicularity. In a related embodiment, third and
fourth transducers (not shown) are added, off of the deflection
axis, to aid an operator with rotational movement and rotational
perpendicularity in the non-deflecting plane of the subject tissue
surface. Additional details of the just-described embodiment are
provided in co-pending U.S. patent application Ser. No. 09/566,196,
filed May 5, 2000, entitled, "Apparatus and Method for Delivering
Therapeutic and Diagnostic Agents," to R. Mueller; incorporated
entirely herein by reference. Ultrasonic transducers may,
preferably, be substituted with one or more force contact
transducers as described in U.S. Provisional Patent Application No.
60/191,610, filed Mar. 23, 2000 by Tom, entirely incorporated by
reference herein.
With respect to hand held, open surgery devices, it is often
important to insure that proper contact force is created between
the device and a target tissue before discharging the device.
Otherwise, the device may inadvertently discharge as it is
manipulated towards a target tissue, or it may, in the case where
too much force is applied, cause perforation of a tissue that is
thinned out as a result of distention caused by excessive force. A
force sensing interlock may be incorporated into the invention thus
only permitting discharge when such force is within a certain
range, both minimally and maximally. For example, ultrasound
transducers, force contact transducers, and mechanical interlocks
having a minimal and maximal limit. Consequently, hand held
needleless hypodermic injector devices, such as those described in
U.S. Pat. Nos. 3,057,349, 3,859,996, 4,266,541, 4,680,027,
5,782,802, each entirely incorporated by reference herein, lacking
interlocks altogether, or only providing interlocks that activate
at a minimum threshold force, without regard to a maximum force
limit, are often inadequate. These handheld needleless injectors
are further limited in that their structure is not amenable for use
inside of a patient cavity created by open surgery, thoroscopic or
other "portal" procedures. For example, each of those disclosures
provides for a snub nosed hand-held gun for use against a patient's
skin, typically a shoulder region of a human. The present invention
provides for an elongated jacket portion of the tool to facilitate
reaching inside a remote region of the patient. The tool distal end
may further be angled or bent, either fixedly, or by bending on
demand, or by remote steering of the distal region of the tool.
FIG. 26 illustrates an open surgical tool where device 1200 has an
elongated jacket portion 1202 having a bend portion 1204, ending in
jet tip 1206 located at distal end 1212 which is where liquid is
ejected when actuator 1208 is compressed thereby causing a liquid
reservoir located around 1210 to deliver fluid to tip 1206 through
a fluid conduit not shown.
Internal to the jacket is one or more lumens, extending between the
jacket's distal and proximal ends. The lumens serve as passages
through which one or more selected agents can pass en route to a
selected tissue or organ. In the arrangement of FIGS. 16A B and 17,
for example, a single lumen, denoted as 222, extends longitudinally
through jacket 216. In another embodiment, shown in FIG. 18, a
plurality of elongate tubes, such as 224a d, extend through a
primary lumen 222 defined by the jacket 216. In this latter
embodiment, each of the tubes includes an internal longitudinal
conduit or channel, defining a respective sub-lumen or delivery
lumen through which one or more agents can pass. Advantageously,
this configuration reduces the dead volume in the system. Also, the
"on/off" response is optimized, and the pressure limit requirement
for the conduit can be readily met.
Catheter jacket 216 terminates at a distal-end face, indicated
generally at 226, defining one or more narrow outlet ports or
orifices, such as 228a d (FIG. 17). Face 226 is configured with a
relatively broad distal surface region of sufficient area to
accommodate a desired number of outlet ports such that each port
can be placed against, or very close to (e.g., within about 5 mm,
and preferably within about 2 mm), a selected wall or surface
region of a target body organ or tissue. Accordingly, one
embodiment provides the distal-end face as a generally blunt
structure with a broad distal surface. For example, in FIGS. 16 18,
a cylindrical plate 232 defines the distal-end face, with the plate
having a distal surface that is substantially planar.
Alternatively, the distal surface can be somewhat curved (e.g.,
convex). One or more bores extend through the plate, between its
proximal and distal broad surfaces, defining outlet ports for the
passage of selected agents.
The plate 232 can be secured along the distal-end region of the
jacket 216 in any suitable manner. In one embodiment, for example,
the plate is attached directly to the distal tip of the jacket, or
in a counterbore formed from the distal tip. Another embodiment,
shown in FIGS. 16 18, contemplates the use of an intermediate
adapter plug or cap, denoted as 234, having a proximal end
configured to fit snugly over the outer circumference of a
distal-end region of jacket 216. The distal portion of the adapter
cap 234 includes an annular counterbore, or stepped region,
configured to receive a peripheral region of the plate 232. Adapter
cap 234 can be formed of a suitable plastic material, such as
polyethylene or nylon, or of a metallic material such as stainless
steel, and bonded to the jacket by heat sealing and/or a
conventional adhesive, or other bonding means. The outlet port(s)
can be formed, for example, by laser boring, photochemical
machining, or other suitable technique; or the plate and bores can
be formed together as a molded component.
With further regard to the outlet ports, each is adapted for
communication with one or more of the agent-delivery lumens
extending through the jacket. In a preferred embodiment, there are
from about 1 12 outlet ports (e.g., four, in the illustrated
arrangement), each having a diameter of no greater than about
0.025''; and preferably within a range of from about 0.00025'' to
about 0.020'' (e.g., 0.006''). The size and orientation of each
outlet port serves to direct agents passed through the catheter
lumen(s) in an axial direction, or at an angle no greater than
about 35 degrees off axis (i.e., relative to the catheter's
longitudinal axis at its distal-end region), in the form of a
narrow jet or stream. Axially directed jets or streams can help to
maximize penetration depth, while angled jets or streams can help
to increase the treated area/volume of tissue. Axially directed
jets are illustrated in FIG. 16B, wherein four outlet ports are
configured to direct an agent passed through lumen 222 (indicated
by the large, darkened arrow) axially into a selected tissue 228 as
four separate jets or streams (indicated by the four smaller,
substantially parallel arrows).
The outlet ports can be configured to achieve desired jet or spray
patterns by modifying, for example, the port diameter, length
and/or internal shape. The pressure at the port can also be
adjusted to influence the patterns. Injection streams can be
further modified with secondary injection of additional drug, or a
compatible gas, such as CO.sub.2 and/or other absorbable gas. Such
a gas can be a good accelerator. In addition, a pulsed injection
pattern can be employed to capitalize on tissue recoil effects. In
these regards, attention is directed to FIG. 20A which shows an
exemplary agent-delivery port 268 and a secondary drug or gas port
272 that meets the delivery port 268 at an angle. Also depicted are
several exemplary jet or spray patterns, denoted as "A," "B" and
"C." Pattern "A" (FIG. 20B) can be achieved by passing an agent
through port 268 under pressure, without the use of a secondary
port. Pattern "A" is modified to that of pattern "B" (FIG. 20C) by
additionally passing an agent or gas through secondary port 272.
Pattern "C" (FIG. 20D) is a pulsed spray pattern that can be used
to take advantage of tissue recoil effects. This pattern can be
achieved by passing an agent through port 268 as rapid, controlled
bursts, without the use of a secondary port.
FIGS. 23A D are partial side views of the apparatus of FIG. 18 as
it is placed near a tissue T, such as cardiac tissue (FIG. 23A);
urged against the tissue T (FIG. 23B), thus creating a contact
force between the device and the tissue T, the application of
hydraulic force causing ejection of a fluid stream from each outlet
port thus propelling the fluid into the tissue T (FIG. 23C); and
the removal of hydraulic force and the retention of fluid by the
tissue T within pockets created by hydraulic erosion (FIG.
23D).
In one embodiment, one or more of the agent-delivery lumens and/or
outlet ports includes a valving mechanism operable to regulate
fluid flow therethrough. Such an arrangement can be useful, for
example, for controlling the timing and/or energy of each jet. For
example, a quick-action valve can permit controlled, rapid-fire
bursts from an outlet port. In one embodiment, a first burst causes
a target tissue to recoil and expand, and a subsequent burst then
penetrates the tissue while in an expanded state. An exemplary
valving mechanism is shown in FIG. 21. Here, an elongate needle
plunger 280 has a distal, pointed end 282 that is normally urged
against a seat seal 284 by a coil spring 286, thereby closing a
respective outlet port. Needle 280 can be withdrawn from seat 284,
against the normal bias of spring 286, by pulling on an actuation
line (not shown), manually or otherwise, that connects to a
proximal end of the needle, thereby opening the port. In another
embodiment, a pressure-actuated valving mechanism is employed.
Here, the valve is adapted to open automatically upon reaching a
certain, predetermined threshold pressure at the port.
Employing a needleless injection system such as that shown in FIGS.
16 19 can reduce the tissue damage often associated with the use of
needles. Nevertheless, it should be noted that in certain
circumstances a limited amount of tissue damage at or about the
injection site may be desirable. For example, where angiogenic
agents are being delivered, tissue injury can be beneficial in
creating an environment where the action of such agents is
enhanced. Likewise, when creating a lesion in cardiac tissue to
treat atrial fibrillation, damaging the tissue during the process
of injection may enhance lesion formation by the agent being
injected. Thus, it will sometimes be desired to configure the
outlet ports to produce jet or spray patterns appropriate for
effecting a desired amount of tissue damage over a selected
area.
In addition to the lumen arrangements described above with respect
to FIGS. 16 18, the present invention further contemplates an
assembly including one or more elongate tubular elements that can
be removably received within a primary lumen defined by an outer
elongate sleeve. Each removable tubular element, in this
embodiment, defines a sub-lumen or delivery lumen through which one
or more selected agents can pass, and includes a distal-end face
defining one or more respective outlet ports. Preferably, each
tubular element is adapted to slide longitudinally through the
primary lumen of the elongate sleeve for placement therein and
removal therefrom, as desired.
FIG. 24 illustrates a steerable treatment device 330 in accordance
with one embodiment of the invention. In this embodiment, the
steerable treatment device includes a steerable outer sleeve 340
and a delivery catheter 350. The delivery catheter 350 is slidably
received in the lumen of the outer sleeve 340. The delivery
catheter may include an end member 352 defining a plurality of
outlet ports 355 for delivery of a treatment fluid to target tissue
at a selected treatment site. A distal length 342 of the guide
catheter 340 may be steered by the operator, e.g., by means of
control wires (not shown), causing it to deflect from a relaxed
state (shown in solid lines) to a curved state (shown in phantom
lines). The end member 352 of the delivery catheter 350 can be
positioned at a desired location by controlling the axial
orientation of the guide catheter 340, the curvature of the distal
length 342, and the extent of the end member 352 of the delivery
catheter 350 beyond the distal length 342 of the guide catheter
340.
Another embodiment provides such a tubular element extending
side-by-side with a guidewire lumen from a proximal to a distal end
of an elongate sleeve. In still a further embodiment, such a
tubular element is incorporated in a rapid-exchange
external-guidewire apparatus. In an exemplary construction of the
latter, the tubular element extends longitudinally from a proximal
to a distal end of the elongate sleeve, and runs side-by-side with
a guidewire lumen along a distal region (e.g., about 3 5 mm) of the
sleeve. For example, the present invention can be incorporated in a
rapid-exchange apparatus substantially as taught in U.S. Pat. No.
5,061,273, which is incorporated entirely herein by reference. In
yet a further embodiment, such a tubular element is adapted to be
removed from a lumen extending longitudinally through the sleeve
and replaced with a guidewire for facilitating catheter advancement
across an anatomical structure such as a heart valve.
In a further exemplary arrangement, a guidewire lumen is coaxial
with one or more delivery lumens, with the guidewire lumen at the
center and the delivery lumens surrounding the guidewire lumen. It
is contemplated that the guidewire lumen can be used to place other
elongated devices, if desired, such as ultrasound sensors to
measure wall thickness or pressure sensors to infer contact against
a wall.
An agent reservoir can be utilized for holding a selected
therapeutic and/or diagnostic agent until delivery. The reservoir
can be of any suitable type. In one exemplary construction, the
reservoir is configured to hold a fluidic agent (e.g., in liquid
form) for introduction, using a substantially closed system, into
an agent-delivery lumen of the jacket. For example, the agent can
be held within a chamber provided inside the catheter jacket, or it
can be introduced from an external reservoir (shown schematically
as reservoir 221 in FIG. 15), such as a syringe or bag, via a
conventional introduction port located along the hand unit or along
a proximal region of the jacket. In one embodiment, the hand unit
is provided with a fixed internal reservoir for holding a supply of
a selected agent to be dispensed. In this embodiment, a supply
reservoir, such as a syringe, can communicate with the internal
reservoir via a connector provided in the hand unit's outer
housing. The connector is preferably a substantially sterile
connector, such as a standard Luer-type fitting or other known
standard or proprietary connector. In another embodiment, the
supply reservoir comprises a syringe, pre-loaded with a selected
agent, that can be removably fit into a holding area inside the
housing of the hand unit, as taught, for example, in U.S. Pat. No.
6,183,444, entitled, "Drug Delivery Module," to Glines et al,
incorporated entirely herein by reference.
A pressure control (shown schematically as pump 222 in FIG. 15) is
provided in fluid communication with one or more of the
agent-delivery lumens. The pressure control, e.g., a manual or
automatic pump, is operable to establish an elevated pressure
within such lumen(s) sufficient to propel an agent placed therein
toward, and out of, one or more of the outlet ports, thereby
forming one or more respective fluid jets or streams capable of
penetrating a selected tissue disposed adjacent thereto. In one
embodiment, the pressure control is a hand-operable syringe-type
pump, connected to one or more lumens along a proximal end of the
jacket. Commercially available pressure controls that can be
readily adapted for use herein include, for example, power
injectors, such as the ACIST Injection System Model CL100 (ACIST
Medical Systems), and inflation devices, such as the ARIA or BREEZE
inflation devices from Schneider/Namic (Glen Falls, N.Y.). Examples
of such injection devices are disclosed in U.S. Pat. Nos.
4,592,742, 5,383,851, 5,399,163, 5,520,639, 5,730,723, 5,746,714,
and 5,782,802, each of which is incorporated entirely herein by
reference.
An exemplary method of using the above catheter assembly will now
be described, wherein the catheter assembly is used for
intra-myocardial delivery of a selected therapeutic and/or
diagnostic agent. Initially, catheter shaft 16 is percutaneously
introduced via femoral or radial artery access. Once arterial
access is established, the catheter shaft is slid across the aortic
valve and into the left ventricle chamber. The distal end of the
catheter shaft is maneuvered so as to be substantially
perpendicular to the endocardial wall 228 (FIG. 16B), using
fluoroscopic visualization and/or ultrasound guidance, and pressed
into contact therewith. A selected agent, in fluidic form, is then
introduced into a proximal-end region of lumen 222, and the lumen
is pressurized. Under the influence of such pressure, the agent is
propelled through the lumen, to and out of one or more outlet
ports. In this way, one or more narrow jets or streams are directed
at the endocardial wall.
The depth to which each jet penetrates the tissue being treated may
depend, at least in part, on the pressure at which the fluid is
delivered through the outlet ports and the length of time during
which fluid is delivered. In one embodiment, the operating
parameters are selected such that the jets penetrate to a tissue
depth of at least about 2 10 mm, e.g., about 5 mm. The injection
may be carried out over a time period of about 1 15 seconds. In
certain embodiments, suitable fluid delivery pressures, i.e., the
fluid pressure adjacent the outlet ports, may be about 20 4,500
psi. Lower delivery pressures (e.g., 100 psi or less) may be useful
in introducing low viscosity materials in a more superficial
portion (e.g., less than 2 mm deep) of the tissue being treated.
Higher delivery pressures, such as 400 psi or greater may be
employed where deeper tissue penetration is desired.
In one embodiment particularly well suited for treatment of atrial
fibrillation, delivery pressures are selected to permit the jets to
penetrate the entire thickness of the myocardium. Delivery
pressures in excess of 100 psi, more likely at least about 400 psi,
may suffice; delivery pressures of about 600 2,000 psi are expected
to work well. If the jets penetrate the entire thickness of the
myocardium, a tissue-ablating agent may be retained throughout the
entire thickness of the tissue, creating a fairly precisely
positioned lesion which can extend from one surface of the tissue
to the opposite tissue surface.
This embodiment of the invention can provide a distinct advantage
over processes employing needles to inject fluids into the
myocardium. If a needle is used to inject an ablating agent into
the myocardium, the fluid will exit the needle at a specific
location within the tissue wall. As more fluid is delivered through
the needle, the thickness of the tissue affected by the delivered
fluid will increase. However, the tissue will also tend to diffuse
laterally at the same time. As a consequence, a transmural lesion
created with a needle-based injection may be significantly wider
than necessary. In addition, if the needle is placed imprecisely
with respect to the thickness of the myocardium, a standard volume
of fluid may not be sufficient to extend from one tissue wall to
the other.
If pressurized fluid jets capable of penetrating the entire
thickness of the myocardium are used instead of a needle, an
operator can be assured that the entire thickness of the tissue
will be treated with a predetermined fluid volume. By appropriately
orienting the jets with respect to the tissue surface and one
another, the width of the affected tissue can be controlled. For
example, orienting the outlet ports substantially perpendicular to
the endocardial wall 228 (FIG. 16B), the jets may define a
transmural path that is much more focused than would be achievable
with a needle.
Instead of a catheter-type device, the invention can be
incorporated in other percutaneous and/or surgical devices. For
example, one embodiment contemplates an endoscope-type device
having an elongate shaft with one or more longitudinally extending
lumens extending therethrough. As with the catheter-type device,
the structure defining each lumen (e.g., the endoscope shaft, or
one or more tubes extending through the shaft) is configured to
withstand an elevated pressure (e.g., up to 2000 psi) in the lumen.
Also, like the catheter-type device, a substantially blunt,
distal-end face defines one or more outlet ports communicating with
one or more of the lumens, with each of the outlet ports having a
diameter of about 0.025'' or less (e.g., 0.006''). A pressure
control, such as a pump, is provided in fluid communication with
one or more of the lumens, operable to establish an elevated
pressure within such lumen(s) such that an agent placed therein
will be propelled toward, and out of, one or more of the outlet
ports, thereby forming one or more respective fluid jets or streams
capable of penetrating a selected tissue disposed adjacent thereto
Various other details pertaining to agent delivery are
substantially like those set forth herein with regard to the
catheter-type device.
In an exemplary use, the endoscope-type device of the invention is
introduced thoracoscopically or through a thoracotomy to direct
high-energy jets at the wall or surface of a selected tissue or
organ. For example, one or more high-energy jets can be directed at
the epicardial surface of the heart, permitting one or more
selected agents to penetrate the myocardial tissue. The surgical
device can incorporate a thoracoscopic camera (e.g., a reusable 5
mm camera) axially mounted to provide an operator with a suitable
field of view through a lens. This allows the operator to work
through a common trocar access port placed, for example, through a
patient's chest wall.
It is noted that the above-described methods are merely exemplary
in nature. Those skilled in the art will appreciate that the
present invention provides for the delivery of selected agents to a
wide variety of body organs and regions.
In another embodiment of the present invention, a selected
therapeutic and/or diagnostic agent is held within a reservoir at
the distal-end region of an elongate shaft and delivered into a
tissue by means of ultrasonic energy. Pertinent portions of an
exemplary agent-delivery apparatus, which can be incorporated in a
catheter-type device or an endoscope-type, such as previously
described, are shown in FIG. 19. Here, the distal-end region of a
catheter-type device is shown, having an ultrasonic transducer 252
(e.g., a piezoelectric transducer, such as barium titanate, lead
zirconate titanate, or the like) disposed across lumen 222. The
distal end of the catheter jacket defines a single, relatively
large opening, denoted as 256; however, a cap or plug with one or
more smaller openings (similar to that described above) can be used
instead. The transducer is operable to emit ultrasonic energy, of
appropriate intensity (e.g., up to about 6 watts/cm.sup.2) and
frequency (e.g., up to about 20 MHz), along a generally axial
direction toward a wall or surface region of a selected organ or
tissue 228 within a subject body. The energy, so applied, is
effective to cause an agent 258, held within a holding region near
the distal end of the catheter jacket, to move toward and penetrate
the tissue wall. In one embodiment, the agent is distributed in a
polymer matrix, or other solid or semi-solid form, within the
holding region. The agent is maintained in the matrix within the
holding region until the time of delivery. Alternatively, the agent
(e.g., in liquid or semi-solid form) can be maintained within the
holding region until delivery by providing a semi-permeable
membrane between the agent and the opening at the distal end of the
catheter jacket. Other means for maintaining the agent in the
holding region until delivery will be apparent to those skilled in
the art.
In another embodiment, a selected therapeutic and/or diagnostic
agent is held within a distal-end region of a catheter or
endoscope-type device and propelled into a target tissue or organ
using a biolistic particle-delivery or bombardment assembly. In one
embodiment, the biolistic assembly (e.g., a so-called "gene gun"
incorporated along a distal-end region of the agent-delivery
device) introduces nucleic acid-coated microparticles, such as
DNA-coated metals, into a tissue at high energies. The coated
particles can be propelled into the tissue using any suitable
means, e.g., an explosive burst of an inert gas e.g., (helium), a
mechanical impulse, a centripetal force, and/or an electrostatic
force (See, e.g., U.S. Pat. No. 5,100,792 to Sanford et al.;
incorporated entirely herein by reference). In an exemplary
embodiment, a spark discharge between electrodes placed near the
distal-end region of the catheter, proximal of a distal-end
agent-holding region, is employed to vaporize a water droplet
deposited therebetween, which then creates a shock wave capable of
propelling the DNA-coated particles. The technique allows for the
direct, intracellular delivery of DNA. The carrier particles are
selected based on their availability in defined particle sizes
(e.g., between about 10 and a few micrometers), as well as having a
sufficiently high density to achieve the momentum required for
cellular penetration. Additionally, the particles used are
preferably chemically inert to reduce the likelihood of explosive
oxidation of fine microprojectile powders, as well as non-reactive
with DNA and other components of the precipitating mixes, and
display low toxicity to target cells (See, e.g., Particle
Bombardment Technology for Gene Transfer, (1994) Yang, N. ed.,
Oxford University Press, New York, N.Y., pages 10 11, incorporated
entirely herein by reference). For example, tungsten and/or gold
particle microprojectiles can be employed to achieve adequate gene
transfer frequency by such direct injection techniques.
Alternatively, or in addition, diamond particles, as well as glass,
polystyrene and/or latex beads can be used to carry the DNA. The
DNA-coated particles can be maintained in the agent-holding region
by any suitable means, e.g., precipitated on the distal face of a
carrier sheet suspended across a lumen at or near the distal end of
the jacket. In this latter embodiment, the propulsion means propels
the DNA-coated particles from a distal face of the carrier sheet
into a selected target tissue or organ adjacent thereto.
It will be appreciated that, especially with regard to
catheter-type delivery apparatus, an agent directed from a distal
end of the apparatus with sufficiently high energy may cause such
end to move away from a target tissue wall or surface. FIG. 22, for
example, shows a portion of a steerable catheter 292 having a
distal end positioned adjacent a target region of an endocardial
wall 228 of a patient's left ventricle 294. Arrows "A" and "B"
depict an "action-reaction" phenomenon, with (i) arrow "A"
representing an injection force provided by one or more high-energy
fluid jets or streams directed against the wall 228, with the
jet(s) carrying, for example, an angiogenic agent (e.g., "naked"
DNA), and (ii) arrow "B" representing a resultant,
oppositely-directed force tending to push the distal tip of the
catheter away from the endocardial wall. To counter the latter,
means are provided for maintaining the distal end of the catheter
proximate the endocardial wall. In the illustrated embodiment, a
secondary lumen 296 extends longitudinally along the catheter and
terminates at a distal orifice 298, short of the catheter's distal
end (e.g., by between about 1 4 cm). An elongate wire 302 is
slidably received within the secondary lumen 296 and has its distal
end attached to the catheter at, or near, the catheter's distal
end. From a remote (proximal) location, wire 302 can be moved
between a retracted position, with the distal region of the wire
positioned closely adjacent the catheter (not shown), and an
extended position, with a distal region of the wire extended beyond
the secondary lumen's distal orifice so as to bow away from the
catheter shaft (shown in FIG. 22). At such extended position, a
central region of the bowed portion of the wire presses against a
back wall of the ventricle, as at arrows "E," thereby causing a
distal region of the bowed portion to urge the catheter's distal
end toward the target region of the endocardial wall, as indicated
by arrow "C." In another embodiment, a region of the catheter,
toward its distal end, is configured with a pre-formed (normal)
bend of sufficient stiffness or rigidity to maintain the distal tip
of the shaft proximate the target region of the endocardial wall,
notwithstanding such "action-reaction" forces. For example, a
reinforced external sleeve can be placed over the region "D" of the
catheter shaft to impart the desired bend along such region.
Alternatively, the bend along region "D" can be inducible from a
remote position.
In general, the apparatus and method of the present invention may
employ a wide variety of agents, e.g., ranging from active
compounds to markers to gene therapy compounds. Exemplary agents,
contemplated for use herein, are set forth in U.S. Pat. Nos.
5,840,059; 5,861,397; 5,846,946; 5,703,055; 5,693,622; 5,589,466;
and 5,580,859, each incorporated entirely herein by reference. In
one embodiment, for example, the invention is employed to deliver
one or more genes (e.g., as so-called "naked DNA") into cavities
formed into the myocardium of a subject.
In one embodiment, wherein the agent includes DNA,
controlled-release preparations are formulated through the use of
polymers to complex or absorb the selected gene sequence (with or
without an associated carrier, e.g., liposomes, etc.). The agents
can be formulated according to known methods to prepare
pharmaceutically useful compositions, whereby these materials, or
their functional derivatives, are combined in admixture with a
pharmaceutically acceptable carrier vehicle. Suitable vehicles and
their formulation are described, for example, in Nicolau, C. et al.
(Crit. Rev. Ther. Drug Carrier Syst. 6:239 271 (1989)), which is
incorporated entirely herein by reference. In order to form a
pharmaceutically acceptable composition suitable for effective
administration, such compositions will contain an effective amount
of the desired gene sequence together with a suitable amount of
carrier vehicle.
Additional pharmaceutical methods may be employed to control the
duration of action. Controlled delivery may be exercised by
selecting appropriate macromolecules (for example polyesters,
polyamino acids, polyvinyl, pyrrolidone, ethylenevinylacetate,
methylcellulose, carboxymethylcellulose, or protamine sulfate) and
the concentration of macromolecules as well as the methods of
incorporation in order to control release. Another method to
control the duration of action by controlled release preparations
is to incorporate the agent into particles of a polymeric material
such as polyesters, polyamino acids, hydrogels, poly(lactic acid)
or ethylene vinylacetate copolymers. Alternatively, instead of
incorporating these agents into polymeric particles, it is possible
to entrap these materials in microcapsules prepared, for example,
by coacervation techniques or by interfacial polymerization, for
example, hydroxymethylcellulose or gelatin microcapsules and
poly(methylmethacylate) microcapsules, respectively, or in
colloidal drug delivery systems, for example, liposomes, albumin
microspheres, microemulsions, nanoparticles, or nanocapsules in
macroemulsions.
In a typical use, the agent will enter at one or more target
regions along a surface or wall of a selected tissue, and diffuse
into the tissue, aided by the action of the jets. Advantageously,
the high-energy jets provided herein can be utilized even when the
distal end of the apparatus (e.g., a catheter shaft) is highly
deflected.
FIGS. 27A and 27B illustrate a distal length of a treatment
apparatus 360 in accordance with another embodiment of the
invention that incorporates tissue contact sensors and needleless
injection capabilities. In a manner analogous to the distal end
probe 116 of FIGS. 10A B, the treatment apparatus 360 includes a
series of sensors 370a d, 372a d, and 374a d. These electrodes 370
374 may be arranged concentrically about the lumen 362 of the
treatment apparatus 360. The distal end of the treatment apparatus
is rounded to facilitate detection of the degree of penetration of
the treatment apparatus 360 in a patient's tissue. Unlike the probe
116 of FIG. 10, the treatment apparatus 360 of FIGS. 27A B includes
a distribution plate 364 adjacent a distal end of the lumen 362.
This distribution plate 364 may include a plurality of outlet ports
366, similar to the plate 232 and outlet ports 228 of FIGS. 16 18.
The sensors 370 374 permit an operator to detect, prior to
injecting an agent through the outlet ports 366, when the distal
end of the treatment apparatus 360 (and hence the plate 364) is in
contact with the tissue to be treated.
FIGS. 28A C illustrate a treatment apparatus 400 in accordance with
another embodiment of the invention. The treatment apparatus 400
comprises an elongate body 410, e.g., a catheter, having an
elongate proximal length 412 and a tissue-contacting member 414. A
distal end 416 of the body 410 may be sealed to prevent fluid
delivered through the lumen of the body from exiting the distal end
416. In one embodiment, the tissue-contacting member 414 of the
body 410 is relatively rigid and retains the curved shape shown in
FIGS. 28A C. The proximal length 412 and the tissue-contacting
member 414 may be coplanar. In the illustrated embodiment, which is
well suited for thoracic approaches to the exterior of a patient's
myocardium, the proximal length 412 and tissue-contacting member
414 meet at an angle .theta. of about 90.degree.. The angle .theta.
can be varied as desired, with a suitable range depending on the
nature of the procedure for which the apparatus 400 is employed and
the manner in which the targeted tissue is approached.
If so desired, at least a portion of the length of the
tissue-contacting member 414 of the body 410 may be flexible,
permitting it to deform from the rest configuration. For example,
the tissue-contacting member 414 may be deformed to pass through a
steerable outer sleeve (e.g., sleeve 340 in FIG. 24) or an
intercostally positioned guide canula, then resiliently assume the
curved rest configuration shown in FIGS. 28A C. The rest
configuration of the tissue-contacting member 414 may be selected
as desired to permit it to conform to a surface of the tissue to be
treated. For example, the shape shown in FIGS. 28A C may be adapted
to encircle a portion of a junction between a patient's myocardium
and a pulmonary vein.
A plurality of outlet ports 420a e are arranged along a
tissue-contacting inner surface of the tissue-contacting member
414. Each of these outlet ports 420a e may be in fluid
communication with the lumen of the body 410 so pressurized jets of
fluid (shown schematically by arrows in FIG. 28A) can be directed
toward tissue in contact with the tissue-contacting surface
422.
The tissue-contacting member 414 may include a plurality of sensors
or electrodes 425 adapted to detect surface contact between the
tissue-contacting surface 422 of the body 410 and a surface of
tissue to be treated. In many of the embodiments noted above, the
sensors (e.g., sensors 94 98 of FIGS. 8A B) are carried at a distal
tip of the apparatus. In the embodiment of FIGS. 28A C, though, the
sensors are spaced along the tissue-contacting surface 422, with
one electrode pair 420a d between each pair of adjacent outlet
ports 420a e. By connecting the sensors 425 to an appropriate
control system (e.g., control system 28 in FIG. 1), the areas of
the tissue-contacting surface 422 in contact with tissue can be
detected and displayed in a suitable display (e.g., display 32 in
FIG. 1).
FIGS. 29 32 illustrate alternative embodiments employing
differently shaped tissue-contacting members. The body 430 of FIG.
29 includes a proximal length 432 and a tissue-contacting member
434 with a generally straight tissue-contacting surface 436. A
plurality of outlet ports 440a d are spaced along the
tissue-contacting surface 436 and a sensor 442a c or a sensor pair
(not shown) may be positioned between each adjacent pair of outlet
ports 440.
The body 450 of FIG. 30 includes a proximal length 452 and a
tissue-contacting member 454 with a generally concave
tissue-contacting surface 456. This tissue-contacting member 454 is
similar to the tissue-contacting member 414 of FIGS. 28A C, but the
proximal and tissue-contacting members 452 and 454 are
substantially coplanar rather than meeting at an angle .theta. as
in FIGS. 28A C. A plurality of outlet ports 458 are spaced along
the tissue-contacting surface 456 and a sensor 459 may be
positioned between each adjacent pair of outlet ports 458.
In FIG. 31, the body 460 includes a proximal length 462 and a
tissue-contacting member 464 with an arcuate, generally concave
tissue-contacting surface 466. The tissue-contacting member 464 of
FIG. 31 is similar to the tissue-contacting member 454 of FIG. 30,
but extends through a longer arc. A series of outlet ports 468a g
are spaced along the tissue-contacting surface 466. Three sensors
469a c are spaced from one another along the tissue-contacting
surface 466.
The body 470 of FIG. 32 has a proximal length bending away from the
inner, generally concave tissue-contacting surface 476 of the
body's tissue-contacting member 474. This can facilitate guiding
the tissue contacting surface 476 into surface contact with the
tissue to be treated. A plurality of outlet ports 478 are spaced
along the tissue-contacting surface 476 and a sensor 479 may be
positioned between each adjacent pair of outlet ports 478.
FIGS. 33 35 illustrate a tissue treatment apparatus 500 in
accordance with another embodiment of the invention. The tissue
treatment apparatus 500 generally includes a tissue grasping member
510 and at least one fluid delivery conduit 520. The tissue
grasping member shown in FIG. 33 takes the general form of a pair
of medical pliers or a medical clamp. The tissue grasping member
510 may include a pair of grasping actuators 512a b which are
pivotally connected to one another. The distal length 514 of each
of the grasping actuators 512a b is adapted to contact tissue and
is desirably formed of a biocompatible material, e.g., stainless
steel. Hence, the grasping actuator 512a has a tissue contacting
member 514a and the other grasping actuator 512b has a tissue
contacting member 514b.
As best seen in FIGS. 34 and 35, the tissue contacting member 514a
includes a tissue-contacting face 516 and a recess 518. The recess
518 may take any desired shape. In the illustrated embodiment, the
recess 518 comprises a generally U-shaped channel which extends
along a center line of the tissue contacting member 514a. This
bisects the face 516 into two tissue-contacting surfaces separated
by a gap. The gap may be thought of as a plane extending between
the two tissue-contacting surfaces.
In one embodiment of the invention, the tissue-contacting face 516
comprises an integral surface of the body of the tissue contacting
member 514. In the embodiment shown in FIG. 35, though, the distal
face 516 includes a pair of spaced-apart sensors 540. In a manner
analogous to the sensors described above, these sensors 540 can be
used to detect contact of the tissue contacting member 514 with the
patient's tissue and, if so desired, be used to monitor a
physiological aspect of the tissue. In one embodiment, the sensors
540 comprise a pair of electrodes which are spaced from one another
across the width of the recess 518. By monitoring the current flow
between these two electrodes 540, one can detect when the face 516
of the tissue contacting member 514 is in contact with the
patient's tissue.
The tissue grasping member 510 is adapted to carry at least one
fluid delivery conduit 520 for delivering a fluid to treat a
patient's tissue. In the illustrated embodiment, the tissue
treatment apparatus 500 includes two fluid delivery conduits 520a
b. The first fluid delivery conduit 520a is associated with the
first tissue contacting member 514a and the second fluid delivery
conduit 520b is associated with the second tissue contacting member
514b. The fluid delivery conduits 520a b are in fluid communication
with a fluid reservoir (not shown in FIG. 33 for purposes of
simplicity). The two conduits 520a b can be separately connected to
the reservoir. Alternatively, the two conduits can be joined
proximally of the tissue contacting members 514 and communicate
with the fluid reservoir through a common conduit (not shown). In
another embodiment, only one of the tissue contacting members 514a
b includes a fluid delivery conduit 520. The other tissue
contacting member 514 may simply be used to position tissue against
the tissue-contacting face 516 of the member 514 carrying the fluid
delivery conduit for treatment, as described below. If one of the
tissue contacting members 514 does omit a fluid deliver conduit
520, that tissue contacting member 514 may have a flat
tissue-contacting face 516 without a recess 518 to receive the
conduit 520.
The fluid delivery conduit 520a has a proximal length 528 which
extends proximally of the tissue contacting member 514a and a
distal length 522 which is received within and extends along the
recess 518. (FIG. 34 only shows the first tissue contacting member
514a, but the second tissue contacting member 514b may have
essentially the same structure.) The distal length 522 of the
conduit includes a plurality of spaced-apart fluid delivery ports
524. A distal end 526 of the conduit 520 can be sealed to direct
all of the fluid delivered through the lumen 530 of the conduit 520
through the ports 524.
The recess 518 in the tissue contacting member 514 is adapted to
receive the conduit's distal length 522, or at least the portion of
the distal length 522 which includes the outlet ports 524. The
distal length 522 may be attached to the inner surface of the
recess 518 to keep the distal length 522 in place and orient the
ports 524 outwardly from the recess and toward the gap in the face
516 of the member 514. The distal length 522 can be bonded to the
inner surface of the recess 518 using a biocompatible adhesive, for
example.
The recess 518 is deep enough to permit the outlet ports 524 of the
distal length 522 to be spaced inwardly from the tissue-contacting
face 516 of the member 514. In the illustrated embodiment, the
recess 518 has a depth which is greater than the outer diameter of
the distal length 522. The distance between the outlet port 524 and
a plane extending across the gap in the forward face 516 can be
varied as desired. In one embodiment, the distance is sufficient to
ensure that the outlet ports 524 will be spaced away from the
surface of a tissue being treated. If the tissue being treated is
expected to bulge into the recess, the distance between the port
524 and the face 516 may be greater than if the tissue is not
expected to bulge very far into the recess 518 during ordinary
conditions of use.
FIG. 36 is a schematic cross-sectional view of the tissue treatment
device 500 being used to treat a target tissue 544, exemplified in
this case as tissue of a pulmonary vein 542. While the following
discussion focuses on the use of the tissue treatment apparatus 500
to treat a pulmonary may, it should recognize that the apparatus
500 can be used in a variety of other contexts to inject a suitable
treatment fluid in any tissue which needs to be treated.
The two tissue contacting members 514a b are placed on opposite
sides of the pulmonary vein 542. The grasping actuators 512a b are
moved toward one another to bring the tissue-contacting faces 516
of the tissue contacting members 514a b against the target tissue
544 of the pulmonary vein 542. In particular, the two opposed
tissue contacting members 514 are in contact with the target tissue
544 on opposite sides of the pulmonary vein 542. The fluid delivery
ports 524 of each of the fluid delivery conduits 520 are oriented
inwardly for the pulmonary vein 542. In the illustrated embodiment,
the fluid delivery ports 524 of each conduit 520 are oriented
generally toward the other fluid delivery conduit 520.
As shown in FIG. 36, when the tissue contacting members 514 are
urged against the target tissue 544, the distal length 522 of each
fluid delivery conduit 520a or 520b is spaced a distance from the
surface of the target tissue 544. A treatment fluid, e.g., a tissue
ablating agent, can be delivered through the conduits 520a b and
directed out of the ports 524 in a series of fluid jets 532. In one
embodiment, the pressure of the jets is sufficient to drive fluid
through the entire thickness of the wall of the pulmonary vein 542,
with an excess volume of the fluid being delivered into the lumen
546 of the vein 542. In another embodiment, the pressure may be
reduced to permeate only partially through the thickness of the
target tissue 544. Delivering the pressurized fluid jets in this
fashion permits the apparatus 500 to treat tissue along lines on
opposite sides of the tissue. In the context of treating a
pulmonary vein 542 with a tissue-damaging fluid, this can create
lesions on opposite sides of the pulmonary vein 524 which extend
through the entire thickness of both walls.
Spacing the outlet ports 524 from the tissue being treated can be
advantageous in some applications. As noted above, placing the
outlet ports directly against the tissue will yield a focused
treatment area. Spacing the outlet ports 524 away from the surface
of the tissue will permit the fluid jets to disperse into a
somewhat wider spray pattern, effectively treating a larger tissue
area. In the illustrated embodiment, the width of the spray is con
strained by contact of the face 516 against the tissue being
treated. While this contact need not be fluid tight, the walls of
the recess 518 and the contact between the face 516 and the tissue
will limit dispersion of the fluid to a fairly predictable range.
In the context of ablating tissue in treating atrial fibrillation,
for example, this will yield a lesion in the tissue having a
predictable, reproducible width.
The embodiment illustrated in FIGS. 33 36, which includes a pair of
opposed tissue contacting members 514a b, can also help ensure
proper positioning of the outlet ports 524 with respect to the
tissue being treated. Urging the members 514a b toward one another
will compress the tissue. Urging the members 514a b against the
tissue can pull the tissue more taut, reducing the tendency of the
tissue to recoil under the impact of the pressurized jets 532. The
force against the tissue should not be too great, though. In one
embodiment, the members 514 urge the opposite sides of the
pulmonary vein 542 toward one another, but not far enough to come
into contact.
In One Embodiment of a Method of Treating Tissue, JJJ
FIG. 37A illustrates a tissue treatment apparatus 600 in accordance
with another embodiment of the invention. This tissue treatment
apparatus 600 includes an elongate body 610 with a manually
graspable handle 612 adjacent its proximal end and a distal
grasping member 620 adjacent its distal end. The body 610 and the
distal grasping member 620 may be sized to be introduced into a
patient's thoracic cavity through an intercostal incision. The body
610 may comprise a generally rigid tubular member having a lumen
extending from the handle 612 to the distal end of embodiment
adjacent the distal grasping member 620. The handle 612 may include
an actuator 614 which can be used to move the distal grasping
member 620 between a closed position (shown in FIG. 37A) which may
be used when delivering fluid to treat tissue and an open position
(not shown) adapted to receive the tissue to be treated. Movement
of the actuator 614 can be translated into motion of the distal
grasping member 620 in any desired fashion, e.g., by means of a
flexible cable (not shown). A number of grasping tools adapted for
endoscopic procedures are known in the art and the mechanisms
useful in those devices may be employed to remotely manipulate the
distal grasping member 620 of the tissue treatment apparatus 600 of
FIG. 37A.
A fluid delivery conduit 630 may be employed to deliver a fluid to
treat tissue from a reservoir (not shown in FIG. 37A) to a series
of distally located ports. Although not shown in detail in FIG.
37A, the fluid delivery conduit 630 may bifurcate distally to
provide a pair of distal lengths similar to the distal lengths 522
of the fluid conduits 520a b in the previous embodiment.
FIGS. 38A and 38B illustrate the distal grasping member 620 in
greater detail. The distal grasping member 620 includes a first
tissue contacting member 622a and a second tissue contacting member
622b which can be moved with respect one another between an open
position (FIG. 38A) wherein the tissue contacting members 622 are
spaced from one another and a closed position (FIG. 38B) wherein
the tissue contacting members 622 are closer to one another. A
first branch 632a of the fluid delivery conduit 630 may be
associated with the first tissue contacting member 622a and a
second branch 632b of the fluid delivery conduit 630 may be
associated with the second tissue contacting member 622b. The first
tissue contacting member 622a may include a first tissue contacting
face 624a and the second tissue contacting member 622b may include
an opposed second tissue contacting face 624b. If so desired, the
tissue contacting members 622 may include a recess for receiving
the associated portion of the fluid delivery conduit 630 in a
fashion directly analogous to that described above in connection
with FIGS. 34 36.
FIGS. 39A and 39B illustrate an alternative distal grasping member
640 that may be used in the tissue treatment apparatus 600 instead
of the distal grasping member 620 shown in FIGS. 38A and 38B. The
distal grasping member 640 may include a first tissue contacting
member 642a having a first tissue-contacting face 644a and a second
tissue contacting member 642b having an opposed second
tissue-contacting face 644b. A first branch 632a of the fluid
delivery conduit (630 in FIG. 37A) may be associated with the first
tissue contacting member 642a and a second branch 632b of the fluid
delivery conduit 630 may be associated with the second tissue
contacting member 642b. The primary distinction between the distal
grasping member 640 of FIGS. 39A B and the distal grasping member
620 of FIGS. 38A B is that the tissue contacting members 642 of
FIGS. 39A B are inwardly concave, whereas the tissue contacting
members 622 of FIGS. 38A B have a relatively straight tissue
contacting face 624. As a consequence, the tissue contacting faces
624 may be generally parallel to one another in the closed
orientation (FIG. 38B), defining a relatively straight gap, whereas
the distal grasping member 640 has a more elliptical space between
the tissue contacting faces 644 in the closed configuration (FIG.
39B).
As noted above, the body 610 of the tissue treatment apparatus 600
shown in FIG. 37A may be generally rigid. FIG. 37B illustrates an
alternative embodiment wherein the rigid body 610 is replaced with
a more flexible body 610'. If so desired, the tissue treatment
apparatus may include a flexure control 616 adjacent the handle
612. The flexure control 616 is connected to the body 610' such
that manual movement of the flexure control proximally or distally
(as indicated by the arrows in FIG. 37B) can move the body 610'
between a deflected position (shown in solid lines) and a variety
of straighter positions (one of which is shown in dashed lines).
This can facilitate the proper placement of the distal grasping
member 620 adjacent the target tissue for grasping and subsequent
treatment.
As noted above, forming myocardial lesions to create a "maze" which
helps redirect the cardiac electrical impulse can treat atrial
fibrillation. In accordance which embodiments of the invention,
injecting a tissue-damaging agent into the myocardium may create
such lesions. The tissue-damaging agent may comprise any injectable
fluid agent which, when injected alone or with another agent into
cardiac tissue, will create a lasting, signal-impeding cardiac
lesion suitable for the maze approach to treating atrial
fibrillation. In certain embodiments, the tissue-damaging agent may
comprise a tissue-ablating agent, i.e., a material that will lead
to a permanent destruction of a function of the tissue, such as
effectively conducting cardiac electrical impulses. The
tissue-damaging agent may comprise a liquid, a gas, or both liquid
and gas, such as in the embodiment discussed above in connection
with FIGS. 20A 20C. For example, the tissue-damaging agent may
comprises a fluid ablating agent selected from the group consisting
of alcohols (e.g., ethanol), hypertonic saline (e.g., 10 25%
wt./vol.), thermally-ablating agents, sclerosing agents, and
necrotic antineoplastic agents. Thermally damaging agents may
comprise materials that are biocompatible at or near body
temperature (e.g., saline, glycerine or ethylene glycol), but are
heated so far above or cooled so far below body temperature that
their injection will induce permanent tissue ablation. Hot
injectates which are hot enough to raise the temperature of the
tissue into which it is injected to 50.degree. C. 100.degree. C.
should suffice; cold injectates which are delivered at a
temperature below 0.degree. C., e.g., minus 0.1 5.degree. C., are
expected to work well, too. A variety of sclerosing agents are
known in the art and commercially available, including ethanolamine
oleate (e.g., ETHANOLIN), sodium tedradecyl sulfate (e.g.,
SOTRADECOL), ATHOXYSCLEROL, polyethyleneglycol-monododecylether
(e.g., POLIDOCANOL), sodium morrhuate, and hypertonic saline with
dextrose (e.g., SCLERODEX). Known antineoplastic agents with tissue
necrotic effects include CISPLATIN, DOXORUBICIN and ADRIAMYCIN,
each of which is commercially available.
Methods of Treating Tissue
The apparatus shown in FIGS. 1 40 and detailed above may be used in
a variety of procedures, a number of which are outlined above.
Several embodiments of the invention, however, provide methods for
treating cardiac arrhythmia. While reference is made in the
following discussion to specific apparatus disclosed in the
drawings used to treat cardiac arrhythmia, it should be understood
that this is solely for purposes of illustration and is not
intended to limit the scope of the invention. In particular,
devices other than those shown in the drawings or described above
may be employed to carry out methods in accordance with the
invention, tissues other than cardiac tissue can be treated, and
fluids other than tissue ablating agents can be injected into the
tissue.
As noted above, forming myocardial lesions to create a "maze" which
helps redirect the cardiac electrical impulse can treat atrial
fibrillation. In accordance with embodiments of the invention,
injecting a tissue-damaging agent into the myocardium may create
such lesions. The tissue-damaging agent may comprise any injectable
fluid agent which, when injected alone or with another agent into
cardiac tissue, will create a lasting, signal-impeding cardiac
lesion suitable for the maze approach to treating atrial
fibrillation. In certain embodiments, the tissue-damaging agent may
comprise a tissue-ablating agent, i.e., a material that will lead
to a permanent destruction of a function of the tissue, such as
effectively conducting cardiac electrical impulses. The
tissue-damaging agent may comprise a liquid, a gas, or both liquid
and gas, such as in the embodiment discussed above in connection
with FIGS. 20 20c. For example, the tissue-damaging agent may
comprise a fluid ablating agent selected from the group consisting
of alcohols (e.g., ethanol), hypertonic saline (e.g., 10 25%
wt./vol.), thermally-ablating agents, sclerosing agents, and
necrotic antineoplastic agents. Thermally damaging agents may
comprise materials that are biocompatible at or near body
temperature (e.g., saline, glycerine or ethylene glycol), but are
heated so far above or cooled so far below body temperature that
their injection will induce permanent tissue ablation. Hot
injectates which are hot enough to raise the temperature of the
tissue into which it is injected to 50.degree. 100.degree. C.
should suffice; cold injectates which are delivered at a
temperature below 0.degree. C., e.g., minus 0.1 5.degree. C., are
expected to work well, too. A variety of sclerosing agents are
known in the art and commercially available, including ethanolamine
oleate (e.g., ETHAMOLIN), sodium tedradecyl sulfate (e.g.,
SOTRADECOL), ATHOXYSCLEROL, polyethyleneglycolmonododecylether
(e.g., POLIDOCANOL), sodium morrhuate, and hypertonic saline with
dextrose (e.g., SCLERODEX). Known antineoplastic agents with tissue
necrotic effects include CISPLATIN, DOXORUBICIN and ANDRIAMYCIN,
each of which is commercially available.
The tissue-damaging agent may be delivered through an injectate
delivery device that an operator can control from a position
outside the patient's body. For example, the catheter assembly 212
of FIG. 15 may be employed to inject the agent from the reservoir
221 into the patient's tissue. A tissue-contacting portion of the
injectate delivery device will be guided within the patient's
thoracic cavity into proximity with the selected region of the
heart for treatment. For example, catheter assembly 212 can be
introduced into a patient's femoral artery and the catheter shaft
may be passed through the aortic valve and into the left ventricle
chamber. The distal end 226 of the catheter 216 may be maneuvered
using fluoroscopic and/or ultrasound guidance, as noted above.
Alternatively, the heart may be approached through an intercostal
incision and the delivery device can be positioned or guided within
the thoracic cavity. If so desired, the operator may position an
endoscope within the thoracic cavity to see the location of the
delivery device with respect to the heart.
The tissue-contacting portion of the delivery device may then be
brought into surface contact with the tissue surface of the
patient's cardiac tissue. For example, the distal face 226 of the
catheter assembly 212 (see, e.g., FIG. 18) may be brought into
contact with the tissue surface T, as illustrated in FIG. 23b. As
illustrated in FIGS. 28 32, however, devices in accordance with
other embodiments of the invention employ elongate
tissue-contacting areas and merely urging the distal tip of the
device against the tissue may not bring the intended
tissue-contacting area against the tissue. For example, the body
410 of FIGS. 28A C may be guided adjacent the heart with the
tissue-contacting member 414 deflected (e.g., straightened) from
its relaxed state. Once the tissue-contacting member 414 is
determined to be in the desired position, the operator may allow
the tissue-contacting member 414 to relax and more closely conform
to the tissue surface.
If so desired, the agent may be injected into the cardiac tissue
without separately confirming appropriate contact between the
delivery device and the tissue. In other embodiments of the
invention, however, surface contact between the tissue-contacting
portion of the delivery device and the cardiac tissue surface is
detected before the agent is injected into the tissue. Appropriate
surface contact may be detected in any desired fashion. In
embodiments of the invention, surface contact may be detected by
supplying an excitation voltage to a plurality of electrodes
positioned on the tissue-contacting portion of the body and
measuring a level of at least one current conducted by the
plurality of electrodes, as discussed above.
For example, contact between the distal end probe 130 of FIG. 12A
and the tissue surface can be can be detected using the sensors
136, 138, and 140 and monitoring the display (32 in FIG. 1) until
appropriate surface contact is indicated on the display. Once
appropriate surface contact is detected, the needle 134 can be
advanced distally into the tissue (not shown in FIG. 12) and the
agent can be injected through the needle 134. If a needleless
delivery device such as that shown in FIGS. 28A C is used, surface
contact between the tissue and the tissue-contacting surface 422
can be detected using the sensors 425 and, thereafter, the agent
can be injected as a series of jets from the outlet ports 420a
e.
As noted above, some embodiments of the invention well suited for
treating atrial fibrillation employ pressurized jets of fluid to
inject a tissue-ablating agent into the tissue. Fluid delivery
pressures may be on the order of 400 psi or higher, e.g., 600 2,000
psi. By selecting pressure and other operating parameters, the jets
may be adapted to penetrate 2 mm or more into the cardiac tissue.
In one useful embodiment, the jets are adapted to pass through the
entire thickness of the myocardium, creating a relatively focused
transmural lesion, as discussed above. In such an embodiment, a
quantity of the tissue-ablating agent may pass into the patient's
bloodstream (for injection into the heart from an external delivery
device) or into the thoracic cavity into contact with other organs
or tissue (for injections from outlet ports positioned in the
interior of the heart). In such embodiments, it may be advantageous
to select a tissue-ablating agent that is effective to damage the
cardiac tissue in which it is received, but is not overly
deleterious to the patient if it enters the bloodstream, for
example. For example, ethanol, hypertonic saline and hot saline may
all effectively ablate cardiac tissue to create a transmural
lesion, but reasonable excess fluid volumes may be introduced into
the patient's bloodstream without significant adverse
consequences.
By way of example only, one embodiment that has been found to
function acceptably employs five spaced-apart outlet ports with
diameters of about 0.004 0.008 inches. Delivering about 1 ml of
ethanol at a delivery pressure of about 1000 2000 psi adjacent the
outlet ports creates a transmural lesion in atrium walls having a
thickness of about 3 8 mm. These operating parameters may be
suitable for penetrating entirely through even thicker walls, as
well.
As noted above, embodiments of the invention permit physiological
properties of a tissue (e.g., EKG) to be measured. If so desired,
such a device may be employed to measure the physiological
properties of the cardiac tissue on a real-time basis to monitor
effect of the tissue-damaging agent on the cardiac tissue, helping
ensure that an appropriate cardiac lesion is created. For example,
the needle 162 of FIG. 14 may be used both to deliver the agent and
to collect EKG data indicative of the state of the tissue adjacent
the needle 162. This allows an operator to ensure that a desired
tissue effect is achieved before terminating the procedure or
moving on to another location for further treatment.
The medical device may have a relatively small tissue-contacting
surface delivering tissue to a relatively focused tissue volume
(e.g., the distribution plate 364 of the treatment apparatus 330 of
FIGS. 27A B). If so, a lesion of the desired length may require a
series of injections at spaced-apart locations along the tissue
surface. Repeated repositioning of the device may be reduced, if
not eliminated, by employing a device with an elongate
tissue-contacting member, such as the embodiments of FIGS. 28
32.
Another embodiment provides a method of treating tissue which
involves urging two opposed tissue-contacting members against the
tissue. FIGS. 41 45 schematically illustrate selected applications
of this embodiment to ablate tissue in treating cardiac arrhythmia.
These drawings schematically illustrate a tissue treatment
apparatus 600' similar to that shown in FIG. 37A, but with the
tissue grasping member 620 replaced with the tissue grasping member
640 shown in FIGS. 39A B.
As shown in FIG. 41, the tissue treatment apparatus 600' may be
positioned within a thoracic cavity adjacent the heart 800. The
distally positioned tissue grasping member 640 may be guided toward
one of the pulmonary veins 820a d, e.g., pulmonary vein 820a.
Positioning the tissue grasping member 640 in an open position,
wherein the tissue-contacting members 642 are oriented more away
from one another than in the closed position (FIG. 39B), provides
an area between the two tissue-contacting members 642 within which
the pulmonary vein 820a can be received. With the pulmonary vein
820a received between the tissue-contacting members 642, the
tissue-contacting members 642 can be moved toward one another and
into engagement with a tissue surface of the pulmonary vein
820a.
Although FIG. 36 schematically illustrates use of the tissue
treatment apparatus 500 of FIGS. 33 35, the arrangement of the
tissue-contacting members 642 when brought into contact with the
pulmonary vein 820a may look much the same in cross-section as the
arrangement shown in FIG. 36. In particular, the two
tissue-contacting members 642 may contact the target tissue 544
along a plane through the target tissue, which may be thought of as
a plane extending between the opposed sets of outlet ports in the
fluid delivery conduit 630 (conduits 520a b are shown in the
embodiment of FIG. 36). In a modification of this environment, the
tissue-contacting members are instead brought into contact with a
target location on the atrium of the heart 800 proximal of the
pulmonary vein at a location wherein the pulmonary vein 820a can be
electrically isolated from the rest of the heart.
In some embodiments, the tissue-contacting members 642 may be urged
against the target tissue (544 in FIG. 36) of the pulmonary vein
820a with sufficient force to deform the pulmonary vein 820a. This
will urge segments of the pulmonary vein wall located on opposite
sides of the pulmonary vein 820a toward one another. This can
effectively grasp a length of the pulmonary vein 820a, holding the
target tissue in a relatively stable position for treatment with a
treatment fluid, e.g., a tissue-ablating fluid. If so desired, the
wall segments may be juxtaposed with respect to one another, yet
remain spaced from one another. This permits the blood to continue
to flow through the pulmonary vein 820a in a minimally invasive
procedure and avoids undue damage to the intima of the pulmonary
vein's lumen.
A treatment fluid may then be delivered through the fluid delivery
conduit 630 of the tissue treatment apparatus 600. If the treatment
fluid comprises a tissue-ablating fluid, this will simultaneously
ablate a line of tissue on each side of the wall of the pulmonary
vein 820a to form a transmural lesion along a length of the wall.
The length of this lesion will depend on the length of the
tissue-contacting members 642 and the positioning of the outlet
ports on the fluid delivery conduit 630 carried by the
tissue-contacting members 642. FIG. 42 illustrates a lesion 830a
that extends only along a portion of the wall of the pulmonary vein
820a.
This partial lesion 830 a may be insufficient to effectively
electrically isolate the pulmonary vein 820a from the atrium of the
heart 800. To better isolate the pulmonary vein 820a, the tissue
treatment apparatus 600 may be repositioned so a portion of the
pulmonary vein 820a which remains untreated is positioned between
the tissue-contacting members 642 of the tissue grasping member
640. A second lesion may be formed in much the same fashion as
lesion 830a. This second lesion may adjoin the first lesion 830a to
form a longer, effectively continuous lesion. This process can be
repeated until the resultant series of lesions forms a relatively
continuous lesion 830 that substantially circumscribes the
pulmonary vein 820a, as shown in FIG. 43. Each of the four
pulmonary veins 820a d can be treated in much the same fashion to
effectively electrically isolate the pulmonary veins 820 from the
atrium of the heart 800.
FIGS. 44 and 45 schematically illustrate a slightly different
adaptation of this embodiment, wherein a lesion is formed in the
atrium to isolate to pulmonary veins 820a b from the atrium. In the
embodiment shown in FIG. 44, much the same distal grasping member
640 of the tissue treatment apparatus 600 is illustrated. In this
embodiment, though, the distal grasping member 640 is larger than
the distal grasping member shown in FIGS. 41 and 42, permitting a
lesion 840 to be formed in a single ablating step rather than
requiring a series of separate ablations. As in the embodiment
discussed above in connection with FIGS. 41 43, the
tissue-contacting members 642 may be urged into contact with the
target tissue of the atrium. The opposed inner surfaces of the wall
of the atrium may be brought closer together for the urging force
of the tissue-contacting members 642 and an ablating fluid may be
delivered through the fluid delivery conduit (630 in FIG. 37A) to
ablate atrial tissue, creating the lesion 840.
Various embodiments of the invention have been illustrated and
described. Many alternatives, modifications and variations not
shown or described are within the scope of the invention, and are
available to one of ordinary skill in the art.
* * * * *